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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO PH CAPSULE DELIVERY SYSTEM; ELECTRODE, PH, STOMACH
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GIVEN IMAGING INC. BRAVO PH CAPSULE DELIVERY SYSTEM; ELECTRODE, PH, STOMACH Back to Search Results
Model Number 8956
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Breakdown (2681)
Event Date 03/22/2018
Event Type  malfunction  
Event Description
The physician attempted to deploy the bravo device.The device failed to attached to the esophageal mucosa causing a small tear to the esophagus.A clip was applied and the bleeding was stopped.The capsule was still attached when the device was removed.
 
Event Description
The physician attempted to deploy the bravo device.The device failed to attached to the esophageal mucosa causing a small tear to the esophagus.A clip was applied and the bleeding was stopped.The capsule was still attached when the device was removed.
 
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Brand Name
BRAVO PH CAPSULE DELIVERY SYSTEM
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING INC.
15 hampshire street
mansfield MA 02048
MDR Report Key7489767
MDR Text Key107469882
Report Number7489767
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date11/30/2018
Device Model Number8956
Device Lot Number37871Q
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/10/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/10/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/07/2018
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age48 YR
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