Gelfoam Size 50Recalls & reported problems
Pharmacia & Upjohn Company LLC · Absorbable Hemostatic Sponge, Collagen Based · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10300090323018), received between Oct 25, 2016 and Oct 25, 2016 — 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2016Adverse Event Without Identified Device or Use Problem
EVENT VERBATIM [PREFERRED TERM] GAS BUBBLES WITHIN AN "SPLENIC" INFARCT AFTER EMBOLIZATION [INFARCTION] , INDICATION OF PROXIMAL EMBOLIZATION [PRODUCT USE ISSUE] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM J VASC INTERV RADIOL, 2001, VOL 12, PGS 209-214, ENTITLED "CT FINDINGS AFTER EMBOLIZATION FOR BLUNT SPLENIC TRAUMA". FULL PUBLICATION HAS BEEN REQUESTED. THIS REPORTER REPORTED 6 REPORTS; THIS IS THE 3 OF 6 REPORTS. A PATIENT OF UNSPECIFIED AGE, ETHNICITY AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), INTRAVASCULAR, FROM AN UNSPECIFIED DATE, AT AN UNSPECIFIED DOSE, FOR PROXIMAL EMBOLIZATION AFTER BLUNT SPLENIC INJURY AND UNSPECIFIED MICROCOILS, INTRAVASCULAR, FROM AN UNSPECIFIED DATE, AT AN UNSPECIFIED DOSE FOR SUB-SELECTIVE COIL EMBOLIZATION AFTER BLUNT SPLENIC INJURY. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HAD UNDERGONE SUB-SELECTIVE COIL EMBOLIZATION FOLLOWED BY PROXIMAL EMBOLIZATION WITH ABSORBABLE GELATIN AND COILS AND EXPERIENCED GAS BUBBLES WITHIN AN INFARCT AFTER THE EMBOLIZATION. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE MICROCOILS AND THE OUTCOME OF THE EVENT WAS UNKNOWN. (B)(4) IS THE MARKETING AUTHORIZATI
Patient problems: No Code Available
MAUDE report 6055003 ↗
Other Agent, absorbable hemostatic, collagen based devices
- SURGIFLO® Hemostatic Matrix Kit with Thrombin 2994Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall42 reports
- SURGIFOAM® Absorbable Gelatin Powder Kit 1979Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall2 reports
- Avitene 1050030Davol Inc. · Agent, absorbable hemostatic, collagen based1 recall1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1972Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based24 reports
- SURGIFLO® Hemostatic Matrix 2991Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based17 reports
- Avitene 1010090Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- Avitene 1010020Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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