FOLYSIL SILICONE CATHETER
Report
- Report Number
- 9610711-2024-00218
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Date of Event
- August 1, 2024
- Report Date
- December 20, 2024
- Manufacturer
- COLOPLAST A/S
- Product Code
- EZL
- PMA / PMN Number
- K233411
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9316062 WITH THE SAME DEFECT. WE RECEIVED ONE SAMPLE NOT SEALED WITH SAME ITEM NUMBER AND SAME LOT NUMBER. THIS SAMPLE WAS INFLATED WITH 10ML OF WATER AND NO BURSTING OR BALLOONS DEFECT WERE OBSERVED. BALLOON ISSUE (BURSTING ISSUE, DEFLATING ISSUE) WERE KNOWN AND COULD COME FROM VARIOUS CAUSES BUT ACCORDING TO THE AVAILABLE INFORMATION, WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON PRODUCT: FOLYSIL DHF, DEFECT, BURST FROM SEPTEMBER 2020 TO SEPTEMBER 2024, 178 SIMILAR CASES WERE FOUND. B3: ESTIMATED DATE.
AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9316062 WITH THE SAME DEFECT. B3: ESTIMATED DATE.
ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON EXPLODED DURING INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1478732 | FOLYSIL SILICONE CATHETER | INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL | EZL | COLOPLAST A/S | 9316062_HA61161002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |