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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.
 
Manufacturer Narrative
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 female patient who received aleve tens device direct therapy unit for pain.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient started aleve tens device direct therapy unit.The device material issue (seriousness criteria medically significant and intervention required) and device malfunction ("device is not turning on at all") occurred on an unknown date.It was unknown whether any action was taken 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 20-nov-2018: patient's gender amended to female.New event added: 'device is not turning on at all' was added.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.
 
Manufacturer Narrative
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 female patient who received aleve tens device direct therapy unit for pain.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient started aleve tens device direct therapy unit at an unspecified dose and frequency.The device material issue (seriousness criteria medically significant and intervention required) and device malfunction ("device is not turning on at all") occurred on an unknown date.It was unknown whether any action was taken with aleve tens device direct therapy unit.(b)(4).Quality-safety evaluation of ptc: based on the technical investigation the complaint sample was not returned for analysis.A review of the device history for this serial number was conducted and no defects were identified during the manufacture of the device.This product technical complaint cannot be confirmed at this time.Good faith attempts were made to retrieve the product and/or obtain product information however no further information could be obtained.All aleve direct therapy tens units and gelpads are made in accordance with current good manufacturing practices and to the applicable fda and iso regulations.All product undergoes 100% inspection and 100% functional testing at multiple points throughout the manufacturing process where the associated data and documentation is reviewed to ensure all released product meets product specifications.Without a returned sample, no further investigation is possible.This issue will be monitored and trended to identify potential issues.No complaint sample was available for investigation.Investigation of device history and analysis of production records conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Further company follow-up with the consumer is not possible.The report was amended on (b)(6) 2018 for the following reason: the ccc was amended, as there was no returned sample, this statement was deleted.Additionally, the remote serial number (b)(4) was added.No new follow-up information was received from the reporter.We received serial number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
 
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Brand Name
ALEVE DIRECT THERAPY TENS
Type of Device
STIMULATOR, NERVE, TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS),
Manufacturer (Section D)
BAYER HEALTHCARE LLC, CONSUMER CARE
36 columbia rd.
morristown NJ 07960
MDR Report Key8094646
MDR Text Key128255685
Report Number2248903-2018-00006
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
PMA/PMN Number
K152852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
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 Lay User/Patient
Date Manufacturer Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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