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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY OBERA INTRAGASTRIC BALLOON
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APOLLO ENDOSURGERY OBERA INTRAGASTRIC BALLOON Back to Search Results
Lot Number SN 50042772
Device Problem Insufficient Information (3190)
Patient Problems Gastritis (1874); Inflammation (1932); Ulcer (2274); No Code Available (3191)
Event Date 02/06/2018
Event Type  Injury  
Event Description
Gi testing to determine if site of bleed was upper or lower gi.During second hospitalization, pt received another 3 units of blood and was transported to local hospital for intragastric balloon removal.Operative report note states no obvious blood present but coffee ground material suspicious for possible old blood.A small ulcer was noted at the gastric antrum above the pylorus which was non-bleeding and fairly superficial.Some fairly mild gastritis and esophagitis in area noted but no obvious site of bleeding.Pt stabilized and discharged with instructions to undergo out pt lower gi testing.
 
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Brand Name
OBERA INTRAGASTRIC BALLOON
Type of Device
OBERA
Manufacturer (Section D)
APOLLO ENDOSURGERY
1120 s. capital of texas hwy
bldg 1, ste 300
austin TX 78746
MDR Report Key7302869
MDR Text Key101346324
Report Number7302869
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 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberSN 50042772
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/06/2018
Event Location Outpatient Treatment Facility
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/23/2018
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) Hospitalization; Life Threatening;
Patient Age51 YR
Patient Weight76
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