FDA Adverse Event
Malfunction
Summary report: N
FOLEY CATHETER, 2W HARD VALVE STD CH16
MDR report key: 2922172
·
Received January 16, 2013
Report
- Report Number
- 9611710-2013-00005
- Event Type
- Malfunction
- Date Received
- January 16, 2013
- Date of Event
- April 19, 2012
- Report Date
- January 16, 2013
- Manufacturer
- UNOMEDICAL SDN BHD
- Product Code
- KOD
- PMA / PMN Number
- K770256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(4). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM FEI (B)(4)). BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE IN SOME CASES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON HAS FAILED TO DEFLATE. REPORTED TO THE FDA ON (B)(4) 2013.
Description of Event or Problem · 1
BALLOON WILL NOT DEFLATE. NO HARM OR INJURY TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24833 | FOLEY CATHETER, 2W HARD VALVE STD CH16 | UROLOGICAL CATHETER AND ACCESSORIES | KOD | UNOMEDICAL SDN BHD | MM51161610 | 403277R001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |