MalfunctionFFF
BRAVO
Received Dec 15, 2011
Report 9710107-2011-01365 · MDR key 2410758
Device
Generic name
Bravo Ph Capsule
Manufacturer
Given Imaging Ltd.Model number
BRAVO PH CAPSULECatalog number
FGS-0313
Lot number
16580Q
Product problems
- Failure To Adhere Or Bond
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS CASE WAS REPORTED FROM (B)(6). CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO ATTACH. THE PATIENT WAS NOT INJURED FOLLOWING THE PROCEDURE.