N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908815
- MDR report key
- 9908815
- Report number
- 9710107-2020-00181
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-13
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- AMY BEEMAN
- Address
- 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US
- Phone
- 763-763-7632
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BRAVO | ELECTRODE, PH, STOMACH | GIVEN IMAGING LTD., YOQNEAM | FFT | FGS-0636 | FGS-0636 | 48088F | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND USER HARM AND THE CAPSULE WAS REMOVED WITH A ROTH NET. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE.