MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2003-10-08 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Codman & Shurtleff, Inc..
[329914]
International affiliate reports the pt had a vein stripped in july 2003. The procedure went well and the veins were removed and wounds were sutured closed. The pt complained of a lump in the leg. The pt was admitted in september 2003 and the foriegn body was removed. The foreign body was the small olive which was attached onto the stripper cable. The olive had apparently separated from the cable during the original vein stripping procedure. No product is being returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2003-00230 |
| MDR Report Key | 487948 |
| Report Source | 01,05,07 |
| Date Received | 2003-10-08 |
| Date of Report | 2003-09-24 |
| Date of Event | 2003-07-22 |
| Date Mfgr Received | 2003-09-24 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2003-10-10 |
| 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 | 2003-10-08 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | CV512 |
| ID Number | NA |
| Device Expiration Date | 2003-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 476808 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 027670350 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. Required No Informationntervention | 2003-10-08 |