FDA Adverse Event
Malfunction
Summary report: N
RUSCH 100 PERCENT SILICONE FOLEY CATHETER, 14FR
MDR report key: 1931932
·
Received November 29, 2010
Report
- Report Number
- 8040412-2010-00100
- Event Type
- Malfunction
- Date Received
- November 29, 2010
- Report Date
- November 3, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KOD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WILL BE SENT BY THE FRENCH AFFILIATE TO THE MFG FACILITY FOR EVAL. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: A SMALL HERNIA REMAINS AT THE DISTAL END OF THE BALLOON AFTER IT IS DEFLATED. THERE WAS SOME PAIN FOR THE PT DURING WITHDRAWAL OF THE CATHETER. NO PT INJURY OR INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH 100 PERCENT SILICONE FOLEY CATHETER, 14FR | UROLOGICAL FOLEY CATHETER | KOD | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |