FDA Adverse Event
Malfunction
Summary report: N
SAFFRON
MDR report key: 19665652
·
Received July 3, 2024
Report
- Report Number
- 19665652
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Date of Event
- October 19, 2023
- Report Date
- April 11, 2024
- Manufacturer
- COLOPLAST CORP
- Product Code
- PBQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DEVICE WOULD NOT ACCEPT ANCHOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570723 | SAFFRON | FIXATION, NON-ABSORBABLE OR ABSORBABLE, FOR PELVIC USE | PBQ | COLOPLAST CORP | 520340 | 8808042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |