MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-17 for MYERS INTERCHANGEABLE VEIN STRIPPER * SU11710 manufactured by Allegiance Healthcare Corp.
[307253]
Pt underwent a left vein stripping due to left greater saphenous varicosity using a vein stripper. During the procedure the wire & spring stretched out making the instrument non-functional. The guidewire was removed and the tip was noted to not be intact. The tip of the vein stripper was manually expressed from the vein. The procedure was completed with a 2nd vein stripper.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 439332 |
| MDR Report Key | 439332 |
| Date Received | 2003-01-17 |
| Date of Report | 2003-01-17 |
| Date of Event | 2003-01-10 |
| Date Facility Aware | 2003-01-10 |
| Report Date | 2003-01-17 |
| Date Reported to FDA | 2003-01-17 |
| Date Added to Maude | 2003-01-27 |
| 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 | MYERS INTERCHANGEABLE VEIN STRIPPER |
| Generic Name | VEIN STRIPPING GUIDEWIRE |
| Product Code | GAJ |
| Date Received | 2003-01-17 |
| Model Number | * |
| Catalog Number | SU11710 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 428266 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP |
| Manufacturer Address | P.O. BOX 68530 INDIANAPOLIS IN 46268 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-01-17 |