Gelfoam Size 200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10300090349032), received between May 10, 2019 and May 10, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem

  RED, IRRITATION AND PUSSINESS WHERE IT WAS APPLIED [APPLICATION SITE ABSCESS], RED, IRRITATION AND PUSSINESS WHERE IT WAS APPLIED [APPLICATION SITE ERYTHEMA], RED, IRRITATION AND PUSSINESS WHERE IT WAS APPLIED [APPLICATION SITE IRRITATION]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS PATIENT OF UNSPECIFIED AGE AND GENDER RECEIVED TREATMENT WITH ABSORBABLE GELATIN (GELFOAM) ON AN UNKNOWN DATE; ROUTE OF ADMINISTRATION AND INDICATION UNSPECIFIED. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED THAT "GELFOAM WAS APPLIED AFTER A SKIN BIOPSY ON MY LEG. TODAY THERE IS RED, IRRITATION AND PUSSINESS WHERE IT WAS APPLIED." THE ACTION TAKEN IN RESPONSE TO THE EVENT WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WERE UNKNOWN. UPON FOLLOW UP ON 25APR 2019, INVESTIGATION REPORT RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP. SAP/UNIQUE IDENTIFIER WAS (B)(6) , CLASSIFICATION WAS EXTERNAL CAUSE INVESTIGATION, SUBCLASS WAS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION, SAMPLE STATUS WAS NOT REQUESTED AND UDI WAS (B)(4). ADDITIONAL INFORMATION: THE WORST CASE SEVERITY OF THE REPORTED IS S4. AS OF 09MAY2019, PRODU

  Patient problems: Abscess; Erythema; Irritation

  MAUDE report 8600020 ↗