MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-11 for BIODESIGN OTOLOGIC REPAIR GRAFT G44839 ENT-OTO-0.6-0.9 manufactured by Cook Biotech.
[97013549]
Additional mfg narrative-notes date of event not provided by the complainant, 510(k) k161000 previously k150594. A review of the device lot history records indicated the device was manufactured to specifications. The documented non-conformance would not have contributed to the reported feedback. A total of ten (10) devices was produced from the lot. A review of the cbi complaint database did not reveal any additional complaints associated with the reported lot number. A review of the ifu revealed that perforation and recurrence are amongst the list of potential complications that "are possible with the use of surgical device materials in otologic procedures. " a direct root cause, to the reported perforation persistence and increase in size, is inconclusive. Factors that could contribute to the reported outcome include: patient? S overall health, lack of viable tissue in area being treated, inadequate blood supply to the repair, graft too small for defect, user technique, and patient post-operative care of the treated area and overall post-op patient activities. The reported worsening of the patient? S hearing is a secondary effect of the perforation persistence and/or increase in size.
Patient Sequence No: 1, Text Type: N, H10
[97013550]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2018-00001 |
| MDR Report Key | 7183410 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-11 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2017-06-27 |
| Date Added to Maude | 2018-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODESIGN OTOLOGIC REPAIR GRAFT |
| Generic Name | OTOLOGIC REPAIR GRAFT |
| Product Code | KHJ |
| Date Received | 2018-01-11 |
| Model Number | G44839 |
| Catalog Number | ENT-OTO-0.6-0.9 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-11 |