FDA Adverse Event
Malfunction
Summary report: N
OCCLUDER¿
MDR report key: 7733445
·
Received July 30, 2018
Report
- Report Number
- 3005099803-2018-02516
- Event Type
- Malfunction
- Date Received
- July 30, 2018
- Report Date
- July 1, 2018
- Product Code
- KOD
- PMA / PMN Number
- K841941
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOR THE 1 EVENT REPORTED UNDER EXEMPTION NUMBER E2012014, 1 COMPLAINT DEVICES WAS DISPOSED. 1 EVENT WAS FOUND TO HAVE A ROOT CAUSE OF USER ERROR. CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR "DEVICE NOT RETURNED" FOR ALL RELEVANT EVENTS.
Description of Event or Problem · 1
THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2012014 FOR PRODUCT CODE KOD. THIS REPORT COVERS 1 REPORTED EVENT OF BALLOON BURST/RUPTURED. ALL DEMOGRAPHIC INFORMATION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572987 | OCCLUDER¿ | CATHETER, UROLOGICAL | KOD | M0062201090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |