FDA Adverse Event
Malfunction
Summary report: N
LOFRIC PRIMO
MDR report key: 4342874
·
Received December 11, 2014
Report
- Report Number
- 3009632672-2014-00016
- Event Type
- Malfunction
- Date Received
- December 11, 2014
- Report Date
- December 11, 2014
- Manufacturer
- WELLSPECT HEALTHCARE A DIVISION OF DENTSPLY IH AB
- Product Code
- GBM
- PMA / PMN Number
- K122078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER STATES THAT THE CATHETER DID NOT HAVE ANY EYELETS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 803935 | LOFRIC PRIMO | URINARY CATHETER | GBM | WELLSPECT HEALTHCARE A DIVISION OF DENTSPLY IH AB | 96616 | 156917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |