FDA Adverse Event
Malfunction
Summary report: N
KENDALL DOVER 100% SILICONE FOLEY CATHETER, 18 FR--5CC
MDR report key: 1892904
·
Received November 2, 2010
Report
- Report Number
- MW5018008
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- September 22, 2010
- Report Date
- October 21, 2010
- Manufacturer
- TYCO HEALTHCARE GROUP LP
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT HAS FOLEY CATHETER FOR CONTINUOUS USE AT HOME. PT PRESENTED TO THE HOSPITAL ON (B)(6) 2010 STATING "MY CATHETER BALLOON DEFLATED AND IT FELL OUT. I NEED TO HAVE IT REPLACED." THE PT WAS SEEN ON (B)(6) 2010 FOR THE SCHEDULED CATHETER CHANGE, THEN ON (B)(6) 2010, FOR ANOTHER CATHETER AS THE BALLOON HAD DEFLATED, ON (B)(6) 2010 CATHETER WAS CHANGED BECAUSE PT DID NOT FEEL IT WAS DRAINING CORRECTLY, AND AS NOTED ABOVE ON (B)(6) 2010. (B)(6), RN TOOK A CATHETER OF THE SAME BRAND AND SIZE THE PT WAS USING, INFLATED THE BALLOON AS INSTRUCTED AND OBSERVED THE DEVICE. THE BALLOON DEFLATED SPONTANEOUSLY 3 CM (BALLOON MEASUREMENT) IN TWO WEEKS. TEST CATHETER SENT TO MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENDALL DOVER 100% SILICONE FOLEY CATHETER, 18 FR--5CC | FOLEY CATHETER | KOD | TYCO HEALTHCARE GROUP LP | 0046123 (PROBABLE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |