MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-14 for BIODESIGN OTOLOGIC REPAIR GRAFT G44451 ENT-OTO-2.5X2.5 manufactured by Cook Biotech.
| Report Number | 1835959-2019-00004 |
| MDR Report Key | 9188094 |
| Date Received | 2019-10-14 |
| Date of Report | 2019-10-09 |
| Date Mfgr Received | 2019-09-30 |
| Device Manufacturer Date | 2018-10-23 |
| Date Added to Maude | 2019-10-14 |
| 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 |
| Manufacturer G1 | COOK BIOTECH INCORPORATED |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIODESIGN OTOLOGIC REPAIR GRAFT |
| Generic Name | OTOLOGIC REPAIR GRAFT |
| Product Code | KHJ |
| Date Received | 2019-10-14 |
| Model Number | G44451 |
| Catalog Number | ENT-OTO-2.5X2.5 |
| Lot Number | LB1095593 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2019-10-14 |