Are there safety warnings or adverse event reports for gelatide from FDA's MAUDE or MedWatch databases?
Executive summary
Searchable FDA safety systems exist for devices (MAUDE) and for broader product alerts and voluntary reports (MedWatch); MAUDE contains millions of device reports and is updated monthly (MAUDE). A specific MAUDE entry for “ABSORBABLE GELATIN; SPONGE, STERILE” from Pfizer appears in the database [1] while FDA documentation explains MAUDE’s scope, limits and that reports do not establish causation [2] [3].
1. What the databases are and why they matter
MAUDE is the FDA’s public repository for medical device reports submitted mainly by manufacturers and user facilities; it contains the last ten years of releasable MDRs, is updated monthly, and is intended to help detect device safety signals [2]. MedWatch is the FDA’s safety-information and reporting program used for voluntary reports and for publishing safety alerts about drugs, devices and other products; it offers forms and an online portal for clinicians and consumers [4] [5].
2. Is “gelatide” or gelatin-based products searchable in MAUDE?
MAUDE can be searched for product names and codes and does include entries for gelatin surgical products: the provided search hit shows a MAUDE adverse event report titled “PFIZER, INC. ABSORBABLE GELATIN; SPONGE, STERILE; CLASS III,” demonstrating that gelatin-based surgical hemostats are indexed in MAUDE [1]. The MAUDE interface and downloadable MDR data files allow targeted lookups or bulk analysis [6] [7].
3. What the specific MAUDE entry signals — and what it does not
A MAUDE record for an absorbable gelatin sponge exists in the database as a device report entry [1]. FDA guidance and third‑party analyses emphasize that MAUDE reports are raw submissions: they may contain redactions for trade secrets or personal data, are not verified causal findings, and cannot by themselves determine incidence or causation of adverse events [3] [2]. Researchers also warn of late or incomplete manufacturer reporting that can affect timeliness and data quality [8] [9].
4. MedWatch: would MedWatch list adverse events for a product like gelatide?
MedWatch collects voluntary reports and publishes safety alerts when appropriate, but its public outputs focus on clinically important safety information rather than raw device MDRs; device adverse events are funneled into MAUDE and MDR data files, whereas MedWatch publishes alerts and guidance for clinicians and consumers [4] [10]. If FDA had issued an agency safety alert about a gelatin device, MedWatch would be the place for an official alert [4] [10]. Available sources do not mention any MedWatch safety alert specific to a product named “gelatide.”
5. Known safety concerns around gelatin-containing medical products
Clinical literature and drug/device resources document biologic risks associated with gelatin solutions and gelatin-containing hemostats, including anaphylaxis, bleeding, and renal concerns in some contexts; systematic reviews have cautioned about anaphylaxis and other harms linked to gelatin colloids and called for caution versus alternatives [11] [12]. Regulatory pages on gelatin as a food substance and device classifications exist but do not, in the provided material, list a national alert tied to “gelatide” specifically [13] [14].
6. Data quality, reporting delays and how to interpret any finding
MAUDE is a valuable surveillance tool but has limits: under‑reporting, delayed submissions, missing dates and manufacturer disclaimers all complicate interpretation; recent analyses found a substantial number of late reports to MAUDE and stressed that the database should be interpreted alongside other evidence [8] [15]. The FDA and researchers both caution that MAUDE reports alone do not prove causation [3] [16].
7. How to verify whether there are additional or newer warnings
To confirm current FDA safety actions or newly published MedWatch alerts you must search MAUDE and FDA safety pages directly (MAUDE search and MedWatch pages) and review any agency safety communications because MAUDE entries exist but do not equate to an FDA safety advisory [6] [4]. The MAUDE detail page for the Pfizer absorbable gelatin entry is an example of an indexed report you can open for specifics [1].
8. Bottom line and practical next steps
There is at least one MAUDE record for an absorbable gelatin surgical sponge listed under Pfizer in the MAUDE system [1]. That presence means adverse-event reports exist in MAUDE for gelatin surgical devices, but MAUDE entries do not by themselves prove a product caused harm and publicly available sources here do not report a MedWatch safety alert specifically naming “gelatide” [1] [3] [4]. For definitive, current regulatory status: search MAUDE for the product name and device codes [6], check FDA MedWatch safety alerts [4], and consult clinical literature about gelatin device risks [11].
Limitations: this briefing cites only the supplied documents; I did not access live MAUDE or MedWatch search results beyond the provided MAUDE detail entry and FDA pages, and available sources do not mention a MedWatch alert that uses the name “gelatide.”