MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-26 for BRAVO FGS-0313 manufactured by Given Imaging Ltd., Yoqneam.
[185481447]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185481448]
According to the reporter, immediately after the capsule was placed, the patient felt pain in her chest radiating towards her back and experienced difficulty of breathing after the capsule placement recovery period. The physician advised the patient to take pain medication and was sent home. The patient went to a hospital's emergency room later in the evening for pain with the scale of 7 out of 10, requested the capsule to be removed, and was admitted for pain management. The capsule was not removed as advised by the physician to avoid tearing of the esophageal wall. Chest x-ray was performed and showed that the capsule was still in place, but the emergency physician also refused to remove the capsule. Five days after the capsule was placed, the patient came in for follow-up and had another chest x-ray was performed, and the capsule was no longer attached. The patient was no longer in severe pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00150 |
| MDR Report Key | 9883399 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-26 |
| 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 Country | IL |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVO |
| Generic Name | ELECTRODE, PH, STOMACH |
| Product Code | FFT |
| Date Received | 2020-03-26 |
| Model Number | FGS-0313 |
| Catalog Number | FGS-0313 |
| Operator | HEALTH PROFESSIONAL |
| 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 IL 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |