FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1952628
·
Received December 29, 2010
Report
- Report Number
- 9710107-2010-00918
- Event Type
- Malfunction
- Date Received
- December 29, 2010
- Report Date
- December 29, 2010
- 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
CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO ATTACH. CUSTOMER SUSPECTS THAT THE FAILURE WAS DUE TO EXCESSIVE SECRETIONS IN THE PATIENT'S ESOPHAGUS. THE PT WAS NOT INJURED FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAVO | BRAVO PH CAPSULE | FFT | GIVEN IMAGING LTD. | BRAVO PH CAPSULE | 13979Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |