MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-02 for CODMAN * 63-4031 manufactured by Codman & Shurtleff, Inc..
[329648]
End of stripper came off and remained in the leg. Dr. Was able to retrieve the remainder.
Patient Sequence No: 1, Text Type: D, B5
[373889]
Add'l info rec'd from mfr 1/14/04: mfr examined the device to the extent possible for conformance to specifications. Mfr found the components of the device to meet specifications. Mfr also reviewed the lot history records and found no problems in this documentation. All units in the batch that were released had met a 50-pound tensile proof-load prior to acceptance. Mfr pull tested other units from this lot that had been returned to co from the reporter of this event. All units tested readily exceeded the 50-pound requirement. Mfr has concluded that forces were used during clinical use that far exceeded anticipated, normal use conditions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029725 |
| MDR Report Key | 489710 |
| Date Received | 2003-10-02 |
| Date Added to Maude | 2003-10-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN |
| Generic Name | VEIN STRIPPER |
| Product Code | GAJ |
| Date Received | 2003-10-02 |
| Model Number | * |
| Catalog Number | 63-4031 |
| Lot Number | FV496 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 480765 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE 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 | 2003-10-02 |