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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON; INTRAGASTRIC BALLOON
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RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON; INTRAGASTRIC BALLOON Back to Search Results
Model Number 01-0011-001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vomiting (2144)
Event Date 11/18/2016
Event Type  Injury  
Event Description
The device was inserted without issue on (b)(6) 2016.Patient experienced vomiting for three weeks post-insertion.Due to vomiting, patient was unable to keep her anti-seizure medication down.The physician elected to remove the device on (b)(6) 2016.No further issue was reported.
 
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Brand Name
RESHAPE INTEGRATED DUAL BALLOON
Type of Device
INTRAGASTRIC BALLOON
Manufacturer (Section D)
RESHAPE MEDICAL, INC.
100 calle iglesia
san clemente CA 92672 7502
Manufacturer (Section G)
RESHAPE MEDICAL, INC.
100 calle iglesia
san clemente CA 92672 7502
Manufacturer Contact
greg geissinger
100 calle iglesia
san clemente, CA 92672-7502
9494296680
MDR Report Key6159025
MDR Text Key62086054
Report Number3007934906-2016-00024
Device Sequence Number1
Product Code LTI
UDI-Device IdentifierB001RSM1011
UDI-PublicB001RSM1011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date07/17/2017
Device Model Number01-0011-001
Device Catalogue NumberRSM101
Device Lot Number160727-005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age39 YR
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