FDA Adverse Event
Injury
Summary report: N
LOFRIC PRIMO
MDR report key: 4531567
·
Received February 17, 2015
Report
- Report Number
- 3009632672-2015-00002
- Event Type
- Injury
- Date Received
- February 17, 2015
- Report Date
- January 17, 2015
- Manufacturer
- WELLSPECT HEALTHCARE
- Product Code
- GBM
- PMA / PMN Number
- K050874
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOTS NO: 162614, 164794, 164601.
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION RECEIVED BY THE REPORTER, THE CATHETERS FROM THREE DIFFERENT LOTS WERE BENT AND CAUSED MINOR BLEEDINGS. THE PATIENT IS RECOVERED FROM THE BLEEDINGS. MORE INFORMATION IS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112266 | LOFRIC PRIMO | CATHETER URETHRAL | GBM | WELLSPECT HEALTHCARE | 96612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |