MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-07 for MICRO NERVE HOOK 46-3171 manufactured by Codman.
[91231918]
Patient Sequence No: 1, Text Type: N, H10
[91231919]
The tip of an m-hook instrument broke off while being used during surgery. The broken tip was not retained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7006183 |
| MDR Report Key | 7006183 |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-10-16 |
| Report Date | 2017-10-17 |
| Date Reported to FDA | 2017-10-17 |
| Date Reported to Mfgr | 2017-10-17 |
| Date Added to Maude | 2017-11-07 |
| 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 | MICRO NERVE HOOK |
| Generic Name | HOOK, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2017-11-07 |
| Model Number | 46-3171 |
| Catalog Number | 46-3171 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |