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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 Problems Death (1802); Sepsis (2067); Perforation of Esophagus (2399)
Event Date 03/20/2016
Event Type  Death  
Manufacturer Narrative

There is no known allegation from a health professional that the patient death was related to the device.

 
Event Description

Patient underwent an uneventful balloon insertion on 2/16/16. Patient experienced vomiting and pain and presented at er on (b)(6) 2016; diagnostic evaluation noted presence of kidney stone. Subsequent treatment during er visit, if any, was not reported. Patient presented at implanting surgeon's er on (b)(6) 2016 with severe chest pain. Diagnosed as distal, 1 cm esophageal perforation and leak. Stent placed endoscopically over perforation followed by same day laparoscopic removal of balloon and repair of perforation. Physician noted normal balloon appearance and position. Patient remained hospitalized with sepsis and expired (b)(6) 2016.

 
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Brand NameRESHAPE INTEGRATED DUAL BALLOON
Type of DeviceINTRAGASTRIC 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 Key5582765
MDR Text Key42848134
Report Number3007934906-2016-00006
Device Sequence Number1
Product Code LTI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP140012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2016
Is This An Adverse Event Report? Yes
Device Operator
Device MODEL Number01-0011-001
Device Catalogue NumberRSM101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2016
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 TREATMENT DATA
Date Received: 04/15/2016 Patient Sequence Number: 1
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