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.
[131517598]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131517599]
According to the reporter, after the procedure, the capsule was laying on the patient? S gown. The patient went home and about two hours later, the patient was in the emergency room with a bad sore throat. A morphine was provided, but it did not help. A test was performed to make sure that the patient esophagus was not damaged. It took a good week for the throat pain to subside. It was also noted that the patient had another study done and turned out to be okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-01092 |
| MDR Report Key | 8199726 |
| Report Source | OTHER |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date of Event | 2012-02-01 |
| 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. Required No Informationntervention | 2018-12-27 |