BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00742)
BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00742) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BRAVO; Manufacturer: ARIZONA DEVICE MANUFACTURING; Report number: 2032545-2008-00742.
| Device | BRAVO |
|---|---|
| Manufacturer | ARIZONA DEVICE MANUFACTURING |
| Report number | 2032545-2008-00742 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | User facility |
| Narrative | THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR, THE CAPSULE ATTACHED TO THE PATIENT'S ESOPHAGUS, BUT WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. UPON REMOVAL OF THE DEVICE, THE CAPSULE WAS PULLED OFF OF THE ESOPHAGUS AND FELL INTO THE PATIENT'S STOMACH. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →