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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBERA; ORBERA GASTIC BALLOON

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ORBERA; ORBERA GASTIC BALLOON Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Perforation (2001); Obstruction/Occlusion (2422)
Event Date 09/27/2017
Event Type  malfunction  
Event Description
Pt experienced a gastric outlet obstruction and microperforation of the stomach as a result of the suspected orbera intragastric balloon she had placed in (b)(6).
 
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Brand Name
ORBERA
Type of Device
ORBERA GASTIC BALLOON
MDR Report Key7095221
MDR Text Key94307403
Report Number7095221
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/28/2017
Distributor Facility Aware Date11/22/2017
Device Age1 YR
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/29/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age45 YR
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