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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON
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RESHAPE LIFESCIENCES RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON Back to Search Results
Model Number 01-0011-001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abdominal Pain (1685); Vomiting (2144)
Date of Event 12/31/2018
Type of Reportable Event Serious Injury
Event or Problem Description
The balloon was inserted on (b)(6) 2018.The patient was admitted to the hospital on (b)(6) with severe vomiting, abdominal pain and sweating.The balloon was removed on (b)(6) 2018 and the patient was treated for dehydration.The balloon was removed with no issues and the patient is reported to be stable.
 
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Brand Name
RESHAPE INTEGRATED DUAL BALLOON SYSTEM
Common Device Name
INTRAGASTRIC BALLOON
Manufacturer (Section D)
RESHAPE LIFESCIENCES
100 calle iglesia
san clemente CA 92672 7502
MDR Report Key8310316
Report Number3007934906-2019-00001
Device Sequence Number2229256
Product Code LTI
UDI-Device IdentifierB001RSM1011
UDI-PublicB001RSM1011
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
P140012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 02/06/2019
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
Operator of Device Health Professional
Device Expiration Date07/21/2019
Device Model Number01-0011-001
Device Catalogue NumberRSM101
Device Lot Number180723-002
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/08/2019
Initial Report FDA Received Date02/06/2019
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 Hospitalization;
Patient Age48 YR
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