FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1203214
·
Received October 17, 2008
Report
- Report Number
- 2032545-2008-06638
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 24, 2008
- Manufacturer
- ARIZONA DEVICE MANUFACTURING
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR, WHEN ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP. SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE DID NOT ATTACH TO THE PATIENT'S ESOPHAGUS. THE CAPSULE FELL OFF IN THE PATIENT'S MOUTH WHEN THE DELIVERY SYSTEM WAS BEING REMOVED. NO INJURY TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAVO | FFT | ARIZONA DEVICE MANUFACTURING | 9012B1001 | Q236855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |