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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE LLC, CONSUMER CARE ALEVE DIRECT THERAPY TENS STIMULATOR, NERVE, TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS),

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BAYER HEALTHCARE LLC, CONSUMER CARE ALEVE DIRECT THERAPY TENS STIMULATOR, NERVE, TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS), Back to Search Results
Device Problems Overheating of Device (1437); Insufficient Information (3190); Unexpected Shutdown (4019)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("i think it got hot or warm, i'm not sure") in an adult male patient who received aleve tens device direct therapy unit for pain. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient noticed device material issue (seriousness criteria medically significant). It was unknown whether any action was taken with aleve tens device direct therapy unit. At the time of the report, the device material issue outcome was unknown. The reporter provided no causality assessment for device material issue with aleve tens device direct therapy unit. Further company follow-up with the consumer is not possible. Most recent follow-up information incorporated above includes: on 14-nov-2018: upon internal review of information originally received on 14-nov-2018. The event of i think it got hot or warm, i'm not sure was upgraded to incident event. Device material issue is listed according aleve tens device direct therapy unit and related to the device due to formal reasons. At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury. However there was a potential for harm to the patient if the device issue happened while it was attached to the skin. This case was regarded as incident.
 
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Brand NameALEVE DIRECT THERAPY TENS
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS),
Manufacturer (Section D)
BAYER HEALTHCARE LLC, CONSUMER CARE
36 columbia rd.
morristown NJ 07960
Manufacturer (Section G)
BAYER HEALTHCARE LLC, CONSUMER CARE
36 columbia rd.
morristown NJ 07960
Manufacturer Contact
k shaw lamberson
100 bayer blvd.
p.o. box 915
whippany, NJ 07981-0915
MDR Report Key8094646
MDR Text Key128255685
Report Number2248903-2018-00006
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/21/2018 Patient Sequence Number: 1
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