N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9640140
- MDR report key
- 9640140
- Report number
- 9710107-2020-00040
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-16
- Date received
- 2020-01-28
- 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 | PILLCAM | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE | GIVEN IMAGING LTD., YOQNEAM | NEZ | FGS-0109 | FGS-0109 | 48180 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-28 | 0 | 1. R |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS RETAINED FOR OVER 72 HOURS. THERE WAS NO PATIENT AND USER HARM.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS RETAINED FOR OVER 72 HOURS. THE CUSTOMER CONFIRMED THAT THE CAPSULE WAS RETAINED AT THE ILEO-ILEAL ANASTOMOSIS BY PERFORMING A PLAIN ABDOMINAL X-RAY. 1 WEEK LATER A FOLLOW UP X RAY WAS PERFORMED, AND IT DID NOT SHOW THE RADIO FREQUENCY ID TAG.