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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/27/2018
Event Type  Injury  
Event 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 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
Type of Device
INTRAGASTRIC BALLOON
Manufacturer (Section D)
RESHAPE LIFESCIENCES
100 calle iglesia
san clemente CA 92672 7502
Manufacturer (Section G)
RESHAPE LIFESCIENCES
100 calle iglesia
san clemente CA 92672 7502
Manufacturer Contact
kristin wielenga
100 calle iglesia
san clemente, CA 92672-7502
9492188639
MDR Report Key8189916
MDR Text Key131168239
Report Number3007934906-2018-00037
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 company representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator 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
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Yes
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) Hospitalization; Required Intervention;
Patient Age31 YR
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