MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-27 for UNKNOWN-BRAVO manufactured by Given Imaging Ltd., Yoqneam.
[131518333]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131518334]
According to the reporter, prior to the procedure, the patient was already experiencing nausea, burning sinuses and a burning headache. However, after the placement of the capsule the symptoms worsen, and felt nauseated and? Flu sick?. The patient took carafate and experienced chest pain and severe stomach burning. Seven days post procedure, the patient experienced pain at the capsule site and chest pains. Eleven days post procedure, the patient experienced constant pain in the stomach and burning in the eustachian tubes and sinuses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-01093 |
| MDR Report Key | 8199825 |
| Report Source | OTHER |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date of Event | 2011-05-11 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN-BRAVO |
| Product Code | NSI |
| Date Received | 2018-12-27 |
| Model Number | UNKNOWN-BRAVO |
| Catalog Number | UNKNOWN-BRAVO |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-27 |