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

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).

• Brand Name: ATTAIN, APEX
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): INCONTROL MEDICAL, LLC
• MDR Report Key: 10836622
• MDR Text Key: 216332862
• Report Number: MW5097830
• Device Sequence Number: 1
• Product Code: KPI
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1