FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1851054
·
Received September 28, 2010
Report
- Report Number
- 9710107-2010-00611
- Event Type
- Malfunction
- Date Received
- September 28, 2010
- Date of Event
- September 3, 2010
- Report Date
- September 28, 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 DETACH FROM DELIVERY SYSTEM. CUSTOMER STATES THAT THE DEVICE DID NOT CLICK WHEN THE PLUNGER WAS DEPRESSED. THE PHYSICIAN RECEIVED THE REQUIRED INFO OF EMERGENCY PROCEDURE AND HOW TO RELEASE THE DELIVERY SYSTEM. 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 | 13371Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |