FDA Adverse Event
Injury
Summary report: N
SMALL BOWEL 3 CAPSULE
MDR report key: 5107016
·
Received September 26, 2015
Report
- Report Number
- 9710107-2015-00235
- Event Type
- Injury
- Date Received
- September 26, 2015
- Date of Event
- August 27, 2015
- Report Date
- August 27, 2015
- Manufacturer
- GIVEN IMAGING LTD
- Product Code
- NEZ
- PMA / PMN Number
- K123864
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INITIAL REPORT SENT 09/26/2015 FOLLOW-UP REPORT SENT: 1/5/2016 IT WAS REPORTED THAT THE PATIENT FAILED TO SWALLOW THE CAPSULE TWO TIMES. PATIENT DID NOT CHOKE OR ASPIRATE CAPSULE, AS ORIGINALLY REPORTED. THERE WAS NO HARM TO THE PATIENT.
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE #: (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED (B)(6) STUDY VIDEO SHOWING PATIENT ASPIRATE CAPSULE TWICE DURING THE STUDY. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637568 | SMALL BOWEL 3 CAPSULE | SB3 CAPSULE | NEZ | GIVEN IMAGING LTD | FGS-0391 | 25727U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |