FDA Adverse Event
Malfunction
Summary report: N
INLAY OPTIMA URETERAL STENT
MDR report key: 4173359
·
Received October 10, 2014
Report
- Report Number
- 1018233-2014-00269
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 17, 2014
- Manufacturer
- PRODUCTOS PARA EL CUIDADO DE LA SALUD
- Product Code
- FAD
- PMA / PMN Number
- K043193
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS BROKEN ON ONE END.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643078 | INLAY OPTIMA URETERAL STENT | FAD | FAD | PRODUCTOS PARA EL CUIDADO DE LA SALUD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |