FDA Adverse Event
Malfunction
Summary report: N
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
MDR report key: 2031135
·
Received March 17, 2011
Report
- Report Number
- 9710107-2011-00183
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Report Date
- March 17, 2011
- Manufacturer
- GIVEN IMAGING LTD.
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS CASE WAS REPORTED FROM (B)(6). CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO DETACH FROM DELIVERY SYSTEM. THE PHYSICIAN HAD TO DO EMERGENCY PROCEDURE IN ORDER TO DETACH THE DELIVERY FROM THE CAPSULE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | BRAVO PH CAPSULE | FFT | GIVEN IMAGING LTD. | BRAVO PH CAPSULE | 14612Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |