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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RESHAPE INTRAGASTRIC DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON
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RESHAPE LIFESCIENCES RESHAPE INTRAGASTRIC 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 Code Patient Problem/Medical Problem (2688)
Date of Event 11/27/2018
Type of Reportable Event Serious Injury
Event or Problem Description
The balloon was inserted on (b)(6) 2018.The patient went to the emergency room due to abdominal pain and was diagnosed with pancreatitis.The balloon was removed on (b)(6) 2018.The patient was compliant with taking their ppi's.
 
Event or Problem Description
The balloon was inserted on (b)(6) 2018.The patient went to the emergency room due to abdominal pain and was diagnosed with pancreatitis.The balloon was removed on (b)(6) 2018.The patient was compliant with taking their ppi's.
 
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Brand Name
RESHAPE INTRAGASTRIC DUAL BALLOON SYSTEM
Common Device Name
INTRAGASTRIC BALLOON
Manufacturer (Section D)
RESHAPE LIFESCIENCES
100 calle iglesia
san clemente CA 92672 7502
MDR Report Key8189916
Report Number3007934906-2018-00037
Device Sequence Number1901058
Product Code LTI
UDI-Device IdentifierB001RSM1011
UDI-PublicB001RSM1011
Combination Product (Y/N)N
Initial Reporter StateCO
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,Followup
Report Date (Section B) 01/16/2019
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 Model Number01-0011-001
Device Catalogue NumberRSM101
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Initial Date Received by Manufacturer 11/27/2018
Supplement Date Received by Manufacturer11/27/2018
Initial Report FDA Received Date12/21/2018
Supplement Report FDA Received Date01/16/2019
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; Required Intervention;
Patient Age31 YR
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