MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-11-07 for BRAVO BRAVO PH CAPSULE FGS-0313 manufactured by Given Imaging Ltd..
[16585686]
This case was reported from (b)(6). Customer reported on a bravo ph capsule that failed to detach from delivery system. The patient suffered from slight bleeding on the esophagus. This user placed another capsule to the patient successfully right after the first one failed. No further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2011-01069 |
| MDR Report Key | 2360959 |
| Report Source | 06 |
| Date Received | 2011-11-07 |
| Date of Report | 2011-11-03 |
| Date Added to Maude | 2012-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVO |
| Generic Name | BRAVO PH CAPSULE |
| Product Code | FFR |
| Date Received | 2011-11-07 |
| Model Number | BRAVO PH CAPSULE |
| Catalog Number | FGS-0313 |
| Lot Number | 15787Q |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD. |
| Manufacturer Address | HERMON BLDG., P.O. BOX 258 NEW INDUSTRIAL PARK YOKNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-07 |