FDA Adverse Event
Malfunction
Summary report: N
RUSCH 100% SILICONE 3WAY FOLEY
MDR report key: 1981333
·
Received February 2, 2011
Report
- Report Number
- 8040412-2011-00015
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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: THREE DAYS AFTER INSERTION, THE CATHETER SLID OUT OF THE BLADDER BECAUSE THE BALLOON HAD BURST. NO PT INJURY REPORTED OR REPORT OF RETAINED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH 100% SILICONE 3WAY FOLEY | BLADDER CATHETER | FCM | TELEFLEX MEDICAL | NA | 10HE32 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |