Biodesign G44839Recalls & reported problems

Cook Biotech Incorporated · Biodesign Otologic Repair Graft · Class 2 · Implant

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 00827002448391), received between Jan 11, 2018 and Jan 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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

Device problems

Degraded1

Patient problems

Hearing Loss1
Perforation1
Therapeutic Effects, Unexpected1

Recent adverse event reports

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

InjuryJan 11, 2018Degraded
ON (B)(6) 2017, DR. (B)(6) IMPLANTED AN ENT-OTO-0.6X0.9 FOR REPAIR OF A TYMPANIC MEMBRANE PERFORATION. THIS WAS A CLEAN AND DRY PROCEDURE. NO INFECTION WAS PRESENT AT THE TIME OF DEVICE PLACEMENT. THE PERFORATION WAS SMALL (UNDER 10%) AND CENTRALLY LOCATED. THE DEVICE WAS HYDRATED AND PLACED IN AN UNDERLAY FASHION. GELFOAM WAS PLACED IN THE MIDDLE EAR AND AN UNSPECIFIED OINTMENT WAS USED ON THE EXTERNAL EAR. THE TYMPANIC PERFORATION PERSISTED AND INCREASED IN SIZE. NO INFECTION WAS PRESENT, THE DEVICE DEGRADED / DID NOT REMODEL, BUT IT WAS NOT RETRIEVED. THE PATIENT'S HEARING REPORTEDLY WORSENED FROM THE PRE-OP STATE OF HEARING. THE SURGEON REPORTED THE PATIENT WILL NEED ANOTHER OPERATION.
Patient problems: Hearing Loss; Perforation; Therapeutic Effects, Unexpected
MAUDE report 7183410 ↗

Device details

UDI-DI	`00827002448391`
Brand	Biodesign
Model	G44839
Catalog no.	ENT-OTO-0.6-0.9
Company	Cook Biotech Incorporated
Product code	KHJ · POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)
Class	Class 2
FDA submission	K150594, K161000
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Jul 20, 2026

Device type (GMDN): Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

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All POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.