FDA Adverse Event
Injury
Summary report: N
ALL SILICONE FOLEY CATHETER
MDR report key: 89063
·
Received May 7, 1997
Report
- Report Number
- 9610849-1997-00008
- Event Type
- Injury
- Date Received
- May 7, 1997
- Report Date
- April 10, 1997
- Manufacturer
- KELSAR, S.A.
- Product Code
- FCN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BALLOON WAS COMPLETELY FUNCTIONAL; THE SLIGHT RIDGE NOTED OVER THE BALLOON AREA WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE RIDGE ON THE BALLOON IS A NATURAL CONDITION DUE TO THE INHERENT PHYSICAL PROPERTIES OF THE BALLOON MATERIAL. NO CORRECTIVE ACTION IS NECESSARY. PLEASE NOTE THAT THIS REPORT MAY BE BASED .
Description of Event or Problem · 1
CUSTOMER REPORTS THAT THE CATHETER BALLOON BECAME BAGGY AFTER DEFLATING. THE PT'S URETHRA WAS REPORTEDLY "DAMAGED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALL SILICONE FOLEY CATHETER | FOLEY CATHETER | FCN | KELSAR, S.A. | NA | 899875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |