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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 Problem Death (1802)
Event Date 05/10/2017
Event Type  Death  
Manufacturer Narrative
Manufacturer has attempted to obtain additional information regarding this event, including autopsy results. No further information has been made available.
 
Event Description
Per md, patient had balloon insertion on (b)(6) 2017 without incident. Patient left the office post-procedure alert, oriented, and stable. Per md, md received a phone call from patient's sister the morning of (b)(6) 2017 at 8:30am, indicating the patient had been vomiting off and on throughout the night and seemed lethargic. As the md was speaking with the sister, sister stated the patient vomited again and was "turning blue". Md instructed sister to call 911 immediately. Sister called back later on the morning of (b)(6) 2017 (around 9:30am) indicating the patient had expired.
 
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Brand NameRESHAPE INTEGRATED DUAL BALLOON SYSTEM
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
MDR Report Key6583328
MDR Text Key75714941
Report Number3007934906-2017-00015
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
Type of Report Initial
Report Date 05/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date11/04/2017
Device Model Number01-0011-001
Device Catalogue NumberRSM101
Device Lot Number161107-002
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 Received05/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2017
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: 05/22/2017 Patient Sequence Number: 1
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