MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for V. MEULLER 3763.10 manufactured by Bd/v. Meuller.
[97124469]
Patient Sequence No: 1, Text Type: N, H10
[97124470]
Small piece of metal ball tip from micro neuro nerve hook broke during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7185590 |
| MDR Report Key | 7185590 |
| Date Received | 2018-01-12 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-12-14 |
| Report Date | 2017-12-18 |
| Date Reported to FDA | 2017-12-18 |
| Date Reported to Mfgr | 2017-12-18 |
| Date Added to Maude | 2018-01-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | V. MEULLER |
| Generic Name | INSTRUMENT, MICROSURGICAL |
| Product Code | GZX |
| Date Received | 2018-01-12 |
| Catalog Number | 3763.10 |
| ID Number | MICRO NERVE HOOK |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD/V. MEULLER |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |