FDA Adverse Event
Injury
Summary report: N
PILLCAM
MDR report key: 5006629
·
Received August 13, 2015
Report
- Report Number
- 9710107-2015-00222
- Event Type
- Injury
- Date Received
- August 13, 2015
- Date of Event
- July 31, 2015
- Report Date
- August 13, 2015
- Manufacturer
- GIVEN IMAGING LTD.
- Product Code
- NEZ
- PMA / PMN Number
- K090557
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURE REFERENCE NUMBER: (B)(4).
Additional Manufacturer Narrative · 1
MANUFACTURE REFERENCE NUMBER: (B)(4).
Description of Event or Problem · 1
A PT WITH PEDIATRIC CROHN'S DISEASE SWALLOWED A PATENCY CAPSULE. AN X-RAY PERFORMED 16 HOURS LATER SHOWED THE CAPSULE HAD REACHED THE RECTUM. THE PT PROCEEDED WITH THE PILLCAM SMALL BOWEL CAPSULE PROCEDURE THREE DAYS LATER. THE CAPSULE DID NOT REACH THE COLON. THE CAPSULE WAS REMOVED DURING AN ALREADY PLANNED SURGERY, BUT THIS WAS NOT EXPLICITLY INDICATED BY THE SITE PHYSICIAN. THIS IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536496 | PILLCAM | PILLCAM PATENCY CAPSULE | NEZ | GIVEN IMAGING LTD. | FGS-0109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |