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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE RESHAPE BALLOON SYSTEM (INTEGRATED DUAL); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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RESHAPE RESHAPE BALLOON SYSTEM (INTEGRATED DUAL); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Vertigo (2134); Weakness (2145); Weight Changes (2607)
Event Date 04/08/2016
Event Type  Injury  
Event Description
After having reshape balloon inserted on (b)(6) 2016.On (b)(6) 2016 i suffered a severe gi bleed and went to local e.R.On (b)(6) 2016.Was unable to stand, severe vertigo, severely weak.Was taken by ambulance to (b)(6) where balloon was inserted on (b)(6) 2016 and on (b)(6) 2016 balloon was removed.I have gone from (b)(6) to (b)(6) lbs in 17 days (loss of 38 lbs), i was given 3 units of blood for severe anemia at local e.R.And was told at local e.R.That my heart was being forced to work at 3x normal and that i could arrest at any time.In hospital 4 days.Had endoscopy, colonoscopy and small bowel camera endoscopy and all were negative for source of blood loss.
 
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Brand Name
RESHAPE BALLOON SYSTEM (INTEGRATED DUAL)
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
RESHAPE
MDR Report Key6794137
MDR Text Key82794523
Report NumberMW5071575
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 Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/11/2017
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 No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/11/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age64 YR
Patient Weight62
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