FDA Adverse Event
Injury
Summary report: N
STAINLESS STEEL CABLE
MDR report key: 167657
·
Received May 15, 1998
Report
- Report Number
- 167657
- Event Type
- Injury
- Date Received
- May 15, 1998
- Date of Event
- April 16, 1998
- Report Date
- April 23, 1998
- Manufacturer
- BIOMET
- Product Code
- DZK
- Report Source
- User Facility report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAINLESS STEEL CABLE Implant | STAINLESS STEEL CABLE | DZK | BIOMET | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| R |