FDA Adverse Event
Injury
Summary report: N
SMARTPILL
MDR report key: 10585505
·
Received September 25, 2020
Report
- Report Number
- 9710107-2020-00457
- Event Type
- Injury
- Date Received
- September 25, 2020
- Date of Event
- August 27, 2020
- Report Date
- September 25, 2020
- Manufacturer
- GIVEN IMAGING LTD., YOQNEAM
- Product Code
- NYV
- UDI-DI
- 04260167482712
- PMA / PMN Number
- K092342
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THEY HAD A BLANK STUDY. THE CUSTOMER ADVISED THAT THEY CONFIRMED THE RECEIVER PAIRED WHEN THE PATIENT WAS SENT HOME. THE CUSTOMER WAS INFORMED BY THE PATIENT THAT AFTER THE 3RD DAY, THERE WERE NO PH READINGS. TECHNICAL SUPPORT ADVISED CUSTOMER TO SEND IN STUDY FOR REVIEW. CUSTOMER ALSO STATED THE PATIENT HAD X-RAY AND CONFIRMED CAPSULE HAS PASSED. THERE WAS NO PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1053652 | SMARTPILL | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE | NYV | GIVEN IMAGING LTD., YOQNEAM | 50100100 | 48810P | 04260167482712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |