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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE/APOLLO ENDOSURGERY, INC. RESHAPE BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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RESHAPE/APOLLO ENDOSURGERY, INC. RESHAPE BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Perforation (2001); Sepsis (2067); Test Result (2695)
Event Date 11/12/2018
Event Type  Injury  
Event Description
(b)(6).Dear sir or madam: on (b)(6) 2018, i purchased the reshape balloon procedure for (b)(6) from (b)(6)/dr.(b)(6) at (b)(6).At the time, this procedure was recommended as an option in order to not have a major bariatric surgical operation.This procedure was said to be safer option to assist with weight management.I have been unable to do so for the following reason: this product is designed to stay in the abdominal area for 6 months in order to assist in controlling eating habits.I had my procedure performed on (b)(6) 2018 and just days later, on (b)(6) 2018, the product caused a perforation in my stomach wall, causing uncontrollable pain and caused me to be septic.I had to be rushed by ambulance to icu and then have emergency surgery performed to remove the product due to perforated abdominal viscus and sepsis.I then had to stay in the hospital for 10 more days to monitor the infection due to still having a high white blood cell count from being septic.This caused me to miss multiple weeks of work as i was in the hospital and afterwards as i was recovering from the emergency procedure.If any information can be provided on the steps to recover all or some of the cost of this procedure, please email or call me.I have been trying since 2018 to receive at least a portion of the cost back, with no resolution so far.If you have additional questions for me, i can be reached at (b)(6) or (b)(6).I appreciate any help that can be offered.Sincerely, (b)(6).Sepsis, stomach perforation.Fda safety report id # (b)(4).
 
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Brand Name
RESHAPE BALLOON
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
RESHAPE/APOLLO ENDOSURGERY, INC.
MDR Report Key9632078
MDR Text Key176845144
Report NumberMW5092500
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/22/2020
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? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age40 YR
Patient Weight111
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