MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-05-25 for CODMAN DISPOS VEIN STRIP 63-4031 manufactured by Codman & Shurtleff, Inc..
[447241]
When prof shanik was using the instrument it was reported that the head came off it and fell into the leg of the pt. This resulted in an unnecessary incision. Rep will follow with more details. Uncertain of event date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2006-00125 |
| MDR Report Key | 719639 |
| Report Source | 01,07 |
| Date Received | 2006-05-25 |
| Date Mfgr Received | 2006-04-26 |
| Date Added to Maude | 2006-05-30 |
| 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 DISPOS VEIN STRIP |
| Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Product Code | GAJ |
| Date Received | 2006-05-25 |
| Returned To Mfg | 2006-05-10 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | 000 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 708708 |
| 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. Required No Informationntervention | 2006-05-25 |