MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for BIGOPSY BACKLOADING BIOPSY FORCEPS BLB-024115 manufactured by Cook Ireland Ltd.
| Report Number | 3005580113-2020-00090 |
| MDR Report Key | 9611394 |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date Facility Aware | 2020-01-16 |
| Report Date | 2020-01-21 |
| Date Reported to FDA | 2020-01-21 |
| Date Reported to Mfgr | 2020-01-20 |
| Date Added to Maude | 2020-01-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIGOPSY BACKLOADING BIOPSY FORCEPS |
| Product Code | FCL |
| Date Received | 2020-01-21 |
| Catalog Number | BLB-024115 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-21 |