MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-15 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Depuy.
[15408842]
During vein stripping of left leg, the end nub of stripping device broke off inside the leg. The broken part was visible and was retrieved by an incision in the leg. All pieces of the device are accounted for and saved for quality.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219327 |
| MDR Report Key | 2219327 |
| Date Received | 2011-08-15 |
| Date of Report | 2011-06-28 |
| Date of Event | 2011-06-20 |
| Report Date | 2011-06-28 |
| Date Reported to FDA | 2011-08-15 |
| Date Added to Maude | 2011-08-22 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN DISPOSABLE VEIN STRIPPER |
| Generic Name | CODMAN VEIN STRIPPER |
| Product Code | GAJ |
| Date Received | 2011-08-15 |
| Model Number | DISPOSABLE VEIN STRIPPER |
| Catalog Number | 63-4031 |
| Lot Number | CA672 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-15 |