FDA Adverse Event
Malfunction
Summary report: N
OCCLUDER¿
MDR report key: 7464244
·
Received April 26, 2018
Report
- Report Number
- 3005099803-2018-01395
- Event Type
- Malfunction
- Date Received
- April 26, 2018
- Report Date
- March 31, 2018
- Product Code
- KOD
- PMA / PMN Number
- K841941
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOR THE 2 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012014, BOTH COMPLAINT DEVICES WERE RETURNED. THE 2 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT.
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 2 REPORTED EVENTS OF BALLOONS BURSTS. OF THE EVENTS, 1 PATIENT WAS FEMALE AND 1 WAS MALE. THE KNOWN PATIENTS' AGES RANGED FROM 62 YEARS TO 63 YEARS. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308864 | OCCLUDER¿ | CATHETER, UROLOGICAL | KOD | M0062201070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |