MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-05-03 for CODMAN UNK manufactured by Codman Instruments.
[18527465]
Trauma pt with saw damage, cut to hand w/lacerated muscle, tendon, and nerve. During microsurgical hand repair identified micro pickups and needle holders with malaligned/bent tips; backup set of instruments not readily available. Pt needs additional surgery to repair nerves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2565815 |
| MDR Report Key | 2565815 |
| Report Source | 99 |
| Date Received | 2012-05-03 |
| Date of Report | 2012-05-01 |
| Date of Event | 2012-04-29 |
| Date Facility Aware | 2012-04-29 |
| Report Date | 2012-05-01 |
| Date Added to Maude | 2012-05-10 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN |
| Generic Name | MICROSURGICAL PICKUPS AND NEEDLE HOLDERS |
| Product Code | MJG |
| Date Received | 2012-05-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN INSTRUMENTS |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2012-05-03 |