MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-18 for BRAVO FGS-0636 manufactured by Given Imaging Ltd., Yoqneam.
[183978616]
This product is 510(k) exempt. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183978617]
According to the reporter, the capsule was placed in the usual way. The patient had a forceful cough with in a few seconds of the delivery device removal. The physician used fiber optic scope to re-check, but the capsule was not found. The physician carefully re-inspected entire egd tract and looked inside the mouth and vocal cords with scope, but the capsule was not seen. X-ray of the abdomen and chest was performed. The customer found the capsule on the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00136 |
| MDR Report Key | 9850134 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BRAVO |
| Generic Name | ELECTRODE, PH, STOMACH |
| Product Code | FFT |
| Date Received | 2020-03-18 |
| Model Number | FGS-0636 |
| Catalog Number | FGS-0636 |
| Lot Number | 473368F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-18 |