FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1242892
·
Received November 19, 2008
Report
- Report Number
- 2032545-2008-07598
- Event Type
- Malfunction
- Date Received
- November 19, 2008
- Date of Event
- September 19, 2008
- Report Date
- October 22, 2008
- Manufacturer
- ARIZONA DEVICE MANUFACTURING
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SEE ALSO MANUFACTURER REPORT 2032545200807597. IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR, THE CAPSULE WOULD NOT ATTACH TO THE PT'S ESOPHAGUS. THE CAPSULE FELL OFF INTO THE PT'S STOMACH. IT WAS NOTED THAT THE CAPSULE TROCAR NEEDLE DID NOT ADVANCE. THIS WAS THE SECOND CAPSULE ATTEMPTED FOR THIS PT. THE PROCEDURE WAS NOT COMPLETED. NO INJURY TO THE PT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAVO | FFT | ARIZONA DEVICE MANUFACTURING | 912B1001 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |