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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 Partial thickness (Second Degree) Burn (2694)
Event Date 12/27/2020
Event Type  Injury  
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ('there is one little section on back that looks like it burnt off a couple of layers of skin/ doctor said i had 1st and possibly 2nd degree burns on my back') in a (b)(6)-year-old female patient who received aleve tens device direct therapy unit (batch number tolurn) for pain. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device malfunction "aleve tens unit malfunction". On an unknown date, the patient started aleve tens device direct therapy unit. On 27-dec-2020, the patient experienced medical device site burn (seriousness criteria medically significant and intervention required) with blister, skin wound and pain and medical device site pain ("got almost all the way through the cycle and all of a sudden it hurts as if i was being stung by a bunch of bees"). On an unknown date, the patient experienced sensory disturbance ("nerve endings on back are now super sensitive to any form of heat"). The patient was treated with sulfadiazine silver (silvadene). At the time of the report, the medical device site burn had resolved with sequelae and the sensory disturbance had not resolved. The reporter considered medical device site burn, medical device site pain and sensory disturbance to be related to aleve tens device direct therapy unit. The reporter commented: patient stated she saw her doctor by the time of this report and her doctor said she had 1st and possibly 2nd degree burns on my back. No information about treatment was given. Lot number was provided as tolurn. On addition information received from patient, she stated that now she is unable to use a heating pad or even take a hot shower. It seems that her nerve endings are how hyper sensitive to any form of heat. She said that the product was the sole contributor of her injuries. She went to the doctor because the blister got bigger and quite painful, and she was concerned about infection. Her doctor prescribed silvadene cream to be applied twice daily until the wounds were completely healed. She also said that it appears at this point that she is going to have permanent scarring across her lower back. She hopes that the hyper sensitivity will eventually fade. Manufacturer numbers: 00325866565044; 161130. Most recent follow-up information incorporated above includes: on (b)(6) 2021: the event aleve tens unit malfunction; nerve endings are now super sensitive to any form of heat were added. Wounds and pain were added as symptoms. Treatment drug was added. Outcome for the event there is one little section on back that looks like it burnt off a couple of layers of skin/ doctor said i had 1st and possibly 2nd degree burns on my back was updated. Reporter causality comments were added. 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 Key11552390
MDR Text Key241753926
Report Number2248903-2021-00001
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 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1613538
Device Lot Number629503
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 Received06/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/23/2021 Patient Sequence Number: 1
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