BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00703)
BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00703) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BRAVO; Manufacturer: ARIZONA DEVICE MANUFACTURING; Report number: 2032545-2008-00703.
| Device | BRAVO |
|---|---|
| Manufacturer | ARIZONA DEVICE MANUFACTURING |
| Report number | 2032545-2008-00703 |
| 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 WOULD NOT ATTACH TO THE PATIENT'S ESOPHAGUS. THE CLINICIAN FELT THAT THE CAPSULE TROCAR DID NOT COMPLETELY ADVANCE. THE CAPSULE FELL OFF OF THE DELIVERY SYSTEM UPON REMOVAL FROM THE PATIENT. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED. |
| Source | openFDA MAUDE (device adverse events) |
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