COLLAMEND 1175115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741010590), received between Aug 27, 2024 and Feb 26, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2003 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OPERATIVE NOTES, ¿OVER THE VENTRAL HERNIA IN THE MIDLINE, THE SAC WAS REDUCED AND COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AND SECURED IN PLACE WITH SUTURES CIRCUMFERENTIALLY ON BOTH SUPERIOR AND INFERIOR EDGES.¿ ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH (DEVICE 1) THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE INFECTED OLD MESH (DEVICE 1) WAS DISSECTED FROM SURROUNDING TISSUES AND THEN EXCISED. AN OLD UNKNOWN MESH WAS EXPOSED, AND THIS WAS ALSO EXCISED. THE FASCIA WAS CLEARED AND SYNTHETIC MESH WAS PLACED OVER THE FASCIAL DEFECT AND DEFECT WAS REPAIRED CIRCUMFERENTIALLY WITH SUTURES.¿ (NOTE : THE MESH REMOVED DURING THIS PROCEDURE IS UNKNOWN) ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, IN THE LOWER ABDOMEN, THE FISTULA EXTENDED WITH RECURRENCE OF THE PREVIOUSLY NOTED HERNIA. THE HERNIA DEFECT WAS REDUCED, AND A

  Patient problems: Adhesion(s); Fistula; Scar Tissue; Unspecified Infection

  MAUDE report 24457450 ↗
• InjuryAug 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND PARASTOMAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COLLAMEND FM MESH (DEVICE #1). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. COLLAMEND FM MESH IS INSERTED DIRECTLY AND SUTURED. ¿ (B)(6) 2014 TO (B)(6) 2018 - DURING MULTIPLE VISITS PATIENT HAD ABDOMINAL PAIN, HEMATOMA, ABSCESS, RECURRENT INCISIONAL HERNIA AND BECAME UNWELL WITH FEATURES OF SEPSIS DUE TO PREVIOUS STERCORAL PERFORATION WITH PRESENCE OF ERYTHEMA. (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN ABDOMINAL WALL RECONSTRUCTION WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #2) AND PARTIAL EXPLANT OF COLLAMEND FM (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS IDENTIFIED. THE OLD MESH (DEVICE #1) WAS RELEASED WHEREAS NOT ABLE TO REMOVE ALL THE MESH. A VENTRALIGHT ST MESH (DEVICE #2) WAS PLACED AND SUTURED IN A SUBLAY POSITION.¿ (B)(6) 2018 TO (B)(6) 2022 - DURING MULTIPLE VISITS PATIENT HAD ABDOMINAL PAIN, WOUND DEHISCENCE, SKIN LESION JUST LATERAL TO PREVIOUS ABDOMINAL SCAR, PURULENT DISCHARGE FROM WOUND SINUS, SEPSIS AND HAD ERODING MESH. THIS FILE

  Patient problems: Abscess; Erosion; Hematoma; Hernia; Sepsis; Wound Dehiscence

  MAUDE report 20081385 ↗