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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON
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RESHAPE MEDICAL, INC. RESHAPE INTEGRATED 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 Problems Diarrhea (1811); Inflammation (1932); Thrombus (2101)
Event Date 06/16/2017
Event Type  Injury  
Event Description
Patient developed acute cholecystitis requiring laparoscopic cholecystectomy.Patient.Developed extensive dvt post op, and it was determined that patient had vascular abnormality requiring anticoagulation and vascular procedures.Patient also developed c diff diarrhea and requested balloon removal due togi issues.Date of removal: (b)(6) 2017.
 
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Brand Name
RESHAPE INTEGRATED DUAL BALLOON SYSTEM
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
mary lou mooney
100 calle iglesia
san clemente, CA 92672-7502
9494296680
MDR Report Key6867452
MDR Text Key86247466
Report Number3007934906-2017-00021
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 Other
Type of Report Initial
Report Date 09/14/2017
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
Device Operator Physician
Device Model Number01-0011-001
Device Catalogue NumberRSM101
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/25/2017
Initial Date FDA Received09/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
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