MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-15 for BRAVO BRAVO PH CAPSULE FGS-0313 manufactured by Given Imaging Ltd..
[2431707]
This case was reported from (b)(6). Customer reported on a bravo ph capsule that failed to attach. The patient was not injured following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2011-01365 |
| MDR Report Key | 2410758 |
| Report Source | 06 |
| Date Received | 2011-12-15 |
| Date of Report | 2011-12-15 |
| Date Added to Maude | 2012-02-15 |
| 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 | FFF |
| Date Received | 2011-12-15 |
| Model Number | BRAVO PH CAPSULE |
| Catalog Number | FGS-0313 |
| Lot Number | 16580Q |
| 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, NEW INDUSTRIAL PK P.O. BOX 258 YOKNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-15 |