MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2004-11-10 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Codman & Shurtleff, Inc..
[17889691]
International affiliate reports the tip of the vein strippers cable broke off in the patient's vein. A new cable was used to extract the broken piece.
Patient Sequence No: 1, Text Type: D, B5
[17964247]
Codman has requested the return of the vein stripper for evaluation. A follow up report will be filed upon receipt of the device and completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2004-00348 |
| MDR Report Key | 820842 |
| Report Source | 01,07 |
| Date Received | 2004-11-10 |
| Date of Event | 2004-10-11 |
| Date Mfgr Received | 2004-10-14 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2007-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN DISPOSABLE VEIN STRIPPER |
| Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Product Code | GAJ |
| Date Received | 2004-11-10 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | EU451 |
| ID Number | NA |
| Device Expiration Date | 2007-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 808288 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | CODMAN DISPOSABLE VEIN STRIPPER |
| Baseline Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Baseline Model No | NA |
| Baseline Catalog No | 63-4031 |
| Baseline ID | NA |
| Baseline Device Family | CODMAN DISPOSABLE VEIN STRIPPER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-10 |