MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-01 for JOHNSON & JOHNSON (CODMAN) * 63-4031 manufactured by Johnson & Johnson Healthcare.
[317370]
Diagnosis: varicose vein. Procedure: saphenous stripping. Incident: when removing deep vein stripper from pt's leg, noticed small bullet tip was missing. Ultrasound showed no findings, found on x-ray, located behind knee. Required incision on back of knee for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 488882 |
| MDR Report Key | 488882 |
| Date Received | 2003-10-01 |
| Date of Report | 2003-09-03 |
| Date of Event | 2003-08-27 |
| Date Facility Aware | 2003-08-27 |
| Report Date | 2003-09-03 |
| Date Reported to Mfgr | 2003-09-03 |
| Date Added to Maude | 2003-10-16 |
| 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 |
| 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 | JOHNSON & JOHNSON (CODMAN) |
| Generic Name | DEEP VEIN STRIPPER |
| Product Code | GAJ |
| Date Received | 2003-10-01 |
| Model Number | * |
| Catalog Number | 63-4031 |
| Lot Number | FV495 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 477697 |
| Manufacturer | JOHNSON & JOHNSON HEALTHCARE |
| Manufacturer Address | 425 HOES LANE PO BOX 6800 PISCATAWAY NJ 08855 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 | 2003-10-01 |