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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ALEVE TENS DEVICE DIRECT THERAPY UNIT TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS)

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BAYER HEALTHCARE LLC ALEVE TENS DEVICE DIRECT THERAPY UNIT TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) Back to Search Results
Model Number 1613538
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of device stimulation issue ('it felt like a shock') in a (b)(6)-year-old female patient who received aleve tens device direct therapy unit (batch no. T0kzfp) for pain. The occurrence of additional non-serious events is detailed below. According to the reporter, the patient had no relevant medical history or concurrent conditions. On an unknown date, the patient started aleve tens device direct therapy unit. The device stimulation issue (seriousness criterion medically significant) and device malfunction ("touched the + button once to increase the speed then it just jumped to the highest setting. ") occurred on an unknown date. It was unknown whether any action was taken with aleve tens device direct therapy unit. The reporter commented: i have this for about 3/4 years now and i was using it last night on a few cycles, i touched the " +" button once to increase the speed then it just jumped to the highest setting. I took it off at the very moment then used the remote to stop it. The consumer enquires does that mean it's now defective? most recent follow-up information incorporated above includes: on 12-apr-2021: electrical shock is considered as serious. A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
 
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Brand NameALEVE TENS DEVICE DIRECT THERAPY UNIT
Type of DeviceTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS)
Manufacturer (Section D)
BAYER HEALTHCARE LLC
36 columbia rd.
morristown NJ 07960
Manufacturer (Section G)
BAYER HEALTHCARE LLC
36 columbia rd
morristown NJ 07960
Manufacturer Contact
k. shaw lamberson
100 bayer blvd.
p.o. box 915
whippany, NJ 07981
MDR Report Key11710211
MDR Text Key247772738
Report Number2248903-2021-00002
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
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1613538
Device Lot NumberT0KZFP
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 Received07/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/22/2021 Patient Sequence Number: 1
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