SURGIFOAM Absorbable Gelatin Sponge, U.S.P.Recalls & reported problems across all models
Ferrosan Medical Devices A/S · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 1
- Injuries reported
- 26
- Recalls
- 0
We found 4 models of SURGIFOAM Absorbable Gelatin Sponge, U.S.P. by Ferrosan Medical Devices A/S in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2019 and Sep 24, 2026 — classified as 1 death, 26 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (14 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SURGIFOAM Absorbable Gelatin Sponge, U.S.P. problems
Device problems
- Defective Device14
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Heating4
- Patient-Device Incompatibility3
- Therapeutic or Diagnostic Output Failure2
- Device Contaminated During Manufacture or Shipping1
- Improper or Incorrect Procedure or Method1
- Inadequate Instructions for Healthcare Professional1
Patient problems
- Pain20
- Unspecified Infection20
- Anaphylactic Shock1
- Hypersensitivity/Allergic reaction1
- Meningitis1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Not Applicable1
SURGIFOAM Absorbable Gelatin Sponge, U.S.P. models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1972Agent, Absorbable Hemostatic, Collagen Based24 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1974Agent, Absorbable Hemostatic, Collagen Based2 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1973Agent, Absorbable Hemostatic, Collagen Based1 death1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1975Agent, Absorbable Hemostatic, Collagen Based1 report
Recent SURGIFOAM Absorbable Gelatin Sponge, U.S.P. adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported by the account contact to the sales rep that the patient had an allergic reaction on the sponge of the device.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50879951 ↗MalfunctionJun 5, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE GELATIN WAS USED. THE DEVICE WAS OPENED FOR A CASE AND THE SURGICAL TECH NOTICED THAT THERE WAS A HAIR ON THE ABSORBABLE GELATIN PAD. THE ABSORBABLE GELATIN WAS PASSED OFF THE FIELD AND DID NOT COME IN CONTACT WITH THE PATIENT OR THE BACK TABLE. THEY OPENED A NEW 1975 ABSORBABLE GELATIN PAD TO REPLACE THE ONE WITH THE HAIR ON IT. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410544 ↗InjuryDec 29, 2020Off-Label Use; Off-Label Use
THIS ADVERSE EVENT COMES FROM AN ARTICLE: LAM, F.C. ET AL., AUGMENTED AUTOLOGOUS PERICRANIUM DURAPLASTY IN 100 POSTERIOR FOSSA SURGERIES - A RETROSPECTIVE CASE SERIES, OPERATIVE NEUROSURGERY, VOLUME 71(2), DECEMBER 2012; 302-307. AUTHORS' BACKGROUND: THE AUTHORS ARE WORKING AT DIVISION OF NEUROSURGERY, BETH ISRAEL DEACONESS MEDICAL CENTER, HARVARD UNIVERSITY, BOSTON, MASSACHUSETTS, US. STUDY DESIGN: THE OBJECTIVE WITH THE CASE SERIES IS FOR THE AUTHORS TO REPORT ON THEIR EXPERIENCE USING LOCALLY HARVESTED AUTOLOGOUS PERICRANIUM AS A DURAL SUBSTITUTE IN PATIENTS WHO UNDERWENT POSTERIOR FOSSA SURGERIES. THIS IS A RETROSPECTIVE CASE SERIES OF 100 PATIENTS WHO UNDERWENT ELECTIVE SUBOCCIPITAL CRANIOTOMY AT THE BETH ISRAEL DEACONESS MEDICAL CENTER IN THE PERIOD FROM JULY 2005 TO DECEMBER 2011. OUT OF THE 100 PATIENTS, THE COMPLICATION RATE WAS 1% WITH 1 PATIENT DEVELOPING A NONSTEROIDAL ANTI-INFLAMMATORY DRUG-INDUCED ASEPTIC MENINGITIS AND GRAFT DEHISCENCE REQUIRING SURGICAL REVISION. THE AUTHORS NOTE ON PAGE 306 ". WE COULD DEMONSTRATE BY ALLERGEN TESTING THAT OUR CASE OF ASEPTIC MENINGITIS WAS DUE TO AN NSAID ALLERGY AND NOT SECONDARY TO REACTION TO THE DURAL SEALANT". OUR REFERENCE QN
Patient problems: Meningitis; Wound Dehiscence
MAUDE report 11086749 ↗DeathDec 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND SURGIFOAM WAS USED. A PIECE OF THE SURGIFOAM BECAME LODGED AND MOVED THROUGH THE PATIENT'S INTERNAL MAMMARY ARTERY NEAR THE STERNUM, THEN INTO THE VERTEBRAL AND SUBLCLAVIAN ARTERIES CAUSING THE BASILAR ARTERY OCCLUSION AND THE PATIENT TO HAVE A STROKE. A CTA OF THE NECK AND BRAIN SHOWED THE RVA OCCLUSION. FERROSAN MEDICAL DEVICES (B)(4) REFERENCE NO.: (B)(4). THIS EVENT WAS ORIGINALLY REPORTED AS 3008478369-2018-00003. HOWEVER, A MAUDE SEARCH SHOWED THAT THIS REPORT NUMBER WAS INADVERTENTLY OVERWRITTEN BY THE IMPORTER.
Patient problems: Thromboembolism
MAUDE report 11086468 ↗InjuryMar 20, 2020Therapeutic or Diagnostic Output Failure
THIS REPORT COVERS PATIENT NO. 8 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9858869 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO. 20 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785044 ↗InjuryMar 4, 2020Defective Device; Patient-Device Incompatibility
THIS REPORT COVERS PATIENT NO. 17 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785042 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO. 18 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN 200078684) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785041 ↗InjuryMar 4, 2020Insufficient Heating
THIS REPORT COVERS PATIENT NO. 19 OUT OF 20. PLEASE REFER TO FDA REPORT NO: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO: QN (B)(4)) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785040 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO. 16 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785039 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO. 15 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES (B)(4) REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785036 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO.14 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN 200078684) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785035 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO. 12 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785029 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO. 13 OUT OF 20. PLEASE REFER TO FDA REPORT NO: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO: QN (B)(4)) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9785027 ↗InjuryMar 4, 2020Defective Device
THIS REPORT COVERS PATIENT NO. 9 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN 200078684) FOR EVALUATION OF THIS EVENT.
Patient problems: Pain; Unspecified Infection
MAUDE report 9784641 ↗
Other Ferrosan Medical Devices A/S products
All Ferrosan Medical Devices A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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