SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge 1969Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15712123000141), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

5 other recalls cover devices cleared under the same FDA submission (P990004); they may or may not involve this specific model.

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 18, 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.

• InjuryApr 29, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  ADVERSE EVENT RECEIVED 01.04.2024. IT WAS REPORTED BY THE PATIENT THAT HIS SPONGE IS NOT DISSOLVING FROM HIS DENTAL BONE GRAPH IN HIS LOWER SINUSES. HURT FOR THREE WEEKS. FEELS LIKE IT'S GETTING BETTER. HAS BEEN ON ANTIBIOTICS FOR ALMOST 30 DAYS. PATIENT CAN FEEL AN IRRITATION UNDER HIS LEFT EYE IN THE SINUS AREA PATIENT STILL FEELING PAIN. INFECTION WAS NOTICED TWO WEEKS POST-OP. DR. STATED THE PAIN SHOULD BE GONE SOON. THE DENTIST STATED THAT HE WOULD REMOVE THE SPONGE, BUT HE WOULD ALSO REMOVE THE GRAPH AND THE IMPLANT WHICH THE PATIENT DOES NOT WANT TO DO. PATIENT ALLERGIC TO ANYTHING BOVINE. PATIENT LOOKING FOR INFORMATION ABOUT THE SPONGE AND HOW TO SPEED UP THE DISSOLVING PROCESS OR IF IT NEEDS TO BE REMOVED OR IF HE NEEDS ANOTHER ROUND OF ANTIBIOTICS. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2024 STATING: FOR WHICH INDICATION WAS SURGIFOAM USED? DENTAL IMPLANT, USED AS RETAINING WALLS TO HOLD BONE GRAFT WAS IS YOUR CURRENT STATUS? JUST FINISHED 40 DAY TREATMENT OF ANTIBIOTICS, CURRENTLY IN A WAIT-AND-SEE STATUS. WAS THE ANTIBIOTIC TREATMENT STARTED BEFORE THE SURGERY? NO WAS THERE ANY INDICATION OF AN INFECTION PRIOR SURGERY? NO DOES ETHICON HAVE YOUR PERMISSION TO CONT

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 19200079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990004. One submission often covers many models, so check the product and lot details in each record.

• Z-1881-2024 · Apr 23, 2024 · Open, Classified
  SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
• Z-1584-2022 · May 25, 2022 · Open, Classified
  Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct
• Z-0292-2013 · Aug 21, 2012 · Terminated
  ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed wit
• Z-0293-2013 · Aug 21, 2012 · Terminated
  ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flo
• Z-1897-2012 · Apr 3, 2012 · Terminated
  Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan