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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE MEDICAL RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON
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RESHAPE MEDICAL RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON Back to Search Results
Model Number 01-0011-001
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/25/2018
Type of Reportable Event Malfunction
Event or Problem Description
The balloon was inserted on (b)(6) 2017.The device was scheduled for removal on (b)(6) 2018, 15 - months post insertion.When the egd was performed, there was no balloon found in the stomach.After imaging, there was no radiopaque marker seen within the gi tract.The patient had no blue/green urine and appears to be fine post-op.
 
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Brand Name
RESHAPE INTEGRATED DUAL BALLOON SYSTEM
Common Device Name
INTRAGASTRIC BALLOON
Manufacturer (Section D)
RESHAPE MEDICAL
100 calle iglesia
san clemente CA 92672 7502
MDR Report Key7704587
Report Number3007934906-2018-00025
Device Sequence Number751505
Product Code LTI
UDI-Device IdentifierB001RSM1011
UDI-PublicB001RSM1011
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P140002
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/19/2018
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
Operator of Device Health Professional
Device Expiration Date12/07/2018
Device Model Number01-0011-001
Device Catalogue NumberRSM101
Device Lot Number161214-002
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2018
Initial Report FDA Received Date07/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age41 YR
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