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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INCONTROL MEDICAL, LLC ATTAIN, APEX; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

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INCONTROL MEDICAL, LLC ATTAIN, APEX; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/09/2020
Event Type  malfunction  
Event Description
Reporting false labeling by incontrol medical.They keep advertising a cure and a lifelong cure for incontinence.They have been doing this for years.Fda safety report id# (b)(4).
 
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Brand Name
ATTAIN, APEX
Type of Device
STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
INCONTROL MEDICAL, LLC
MDR Report Key10836622
MDR Text Key216332862
Report NumberMW5097830
Device Sequence Number1
Product Code KPI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/12/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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