FDA Adverse Event
Malfunction
Summary report: N
ULTRACINCH
MDR report key: 1026946
·
Received April 9, 2008
Report
- Report Number
- MW5006162
- Event Type
- Malfunction
- Date Received
- April 9, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 13, 2008
- Manufacturer
- EPICOR MEDICAL INC.
- Product Code
- LPB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IN 2008 @ 10:00 AM EPICOR CABLE SNAPPED IN HALF WHEN APPLYING AROUND THE HEART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACINCH | THORACIC SURGERY | LPB | EPICOR MEDICAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |