MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-15 for STAINLESS STEEL CABLE * 350800 manufactured by Biomet.
[85588]
Cath was removed after evaluation of pt, showed that the cable hab become uncrimped. (2 cables uncrimped). Cable taken by biomet rep and was sent to biomet for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 167657 |
| MDR Report Key | 167657 |
| Date Received | 1998-05-15 |
| Date of Report | 1998-04-23 |
| Date of Event | 1998-04-16 |
| Date Facility Aware | 1998-04-16 |
| Report Date | 1998-04-23 |
| Date Added to Maude | 1998-05-19 |
| 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 | STAINLESS STEEL CABLE |
| Generic Name | STAINLESS STEEL CABLE |
| Product Code | DZK |
| Date Received | 1998-05-15 |
| Returned To Mfg | 1998-04-16 |
| Model Number | * |
| Catalog Number | 350800 |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 163135 |
| Manufacturer | BIOMET |
| Manufacturer Address | PO BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | STAINLESS STEEL CABLE |
| Baseline Generic Name | FIXATION, COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 350800 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1998-05-15 |