BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00735)
BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00735) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BRAVO; Manufacturer: ARIZONA DEVICE MANUFACTURING; Report number: 2032545-2008-00735.
| Device | BRAVO |
|---|---|
| Manufacturer | ARIZONA DEVICE MANUFACTURING |
| Report number | 2032545-2008-00735 |
| 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 TROCAR NEEDLE ADVANCED, BUT THE CAPSULE WOULD NOT ATTACH TO THE PT'S ESOPHAGUS, IT FELL OFF IN THE PT'S MOUTH. THE PT IS RESCHEDULED FOR ANOTHER BRAVO IN SIX WEEKS DUE TO A PUNCTURE WOUND WITHIN THE ESOPHAGUS. FURTHER INFO IS BEING REQUESTED FROM THE HCP. |
| Source | openFDA MAUDE (device adverse events) |
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