MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for DEBAKEY FORCEPS (INSULATED)/DEBAKEY FORCEPS 29-310 manufactured by Unk.
[123941092]
Purchased debakey vase 8" insulated forcep and debakey 2. 8 mm forcep. Prior to use tested for any compromises testing results - positive. Never used on pt. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080558 |
| MDR Report Key | 7965103 |
| Date Received | 2018-10-12 |
| Date Added to Maude | 2018-10-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | DEBAKEY FORCEPS (INSULATED)/DEBAKEY FORCEPS |
| Generic Name | FORCEPS, GENERAL PLASTIC |
| Product Code | GEN |
| Date Received | 2018-10-12 |
| Catalog Number | 29-310 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | DEBAKEY FORCEPS (INSULATED)/DEBAKEY FORCEPS |
| Generic Name | FORCEPS, GENERAL PLASTIC |
| Product Code | GEN |
| Date Received | 2018-10-12 |
| Catalog Number | ASST-AG 9733026 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |