FDA Adverse Event
Malfunction
Summary report: N
PASSPORT¿
MDR report key: 7228581
·
Received January 30, 2018
Report
- Report Number
- 3005099803-2018-00235
- Event Type
- Malfunction
- Date Received
- January 30, 2018
- Report Date
- January 1, 2018
- Product Code
- EZN
- PMA / PMN Number
- K941853
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
FOR THIS 3 EVENTS RELATED TO EXEMPTION NUMBER E 20125012, 2 DEVICES WERE RETURNED AND 1 DEVICE WAS DISPOSED. 1 EVENT HAS A ROOT CAUSE OF USER ERROR, AND 1 EVENT HAS A ROOT CAUSE OF OPERATIONAL CONTEXT.
Description of Event or Problem · 0
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - (B)(4) FOR PRODUCT CODE EZN. THIS REPORT SUMMARIZES 3 EVENT REPORTED TO BOSTON SCIENTIFIC FOR UROMAX ULTRA AND PASSPORT BALLOON CATHETER BALLOON BURST. THE PATIENTS SEX AND AGE ARE BOTH UNKNOWN ALONG WITH ALL OTHER DEMOGRAPHIC INFORMATION .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71924 | PASSPORT¿ | DILATOR, CATHETER, URETERAL | EZN | M0062181100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |