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U.S. Department of Health and Human Services

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

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BAYER HEALTHCARE LLC, CONSUMER CARE ALEVE TENS DEVICE DIRECT THERAPY UNIT STIMULATOR, NERVE, TRANSCUTANEOUS, ELECTRICAL NERVE STIMULATOR (TENS) Back to Search Results
Model Number 1613538
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 08/02/2018
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of medical device site burn ("horrible burns/skin got burned at the application site") in a (b)(6)year-old female patient who received aleve tens device direct therapy unit for sciatica. Other product or product use issues identified: device use issue "aleve tens used for sciatica pain" on (b)(6) 2018 and device malfunction "device malfunction". Medical conditions: no concomitant drugs. On an unknown date, the patient started aleve tens device direct therapy unit. On (b)(6) 2018, the patient experienced medical device site burn (seriousness criterion medically significant) with medical device site erythema and medical device site pain. The patient was treated with naproxen sodium (aleve caplet). At the time of the report, the medical device site burn had not resolved. The reporter considered medical device site burn to be related to aleve tens device direct therapy unit. The reporter commented: sciatica pain diagnosed in (b)(6) 2018. It was the first time patient used the aleve tens. Patient carefully read the instructions. Device purchased on (b)(6) 2018 and used on the same day (30 minutes cycle during the night). While she was in the shower in the morning on (b)(6) 2018, she noticed the areas where the gel pad was being sensitive. Later on when she looked at the mirror she noticed that it was red and burned. According to patient no excessive or unusual device output noticed during treatment, no lubricant or foreign substances or cleaning agents used on the gel pad and device was not damaged. Gel pads lot number and expiration date unknown. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20. 7 kg/sqm. Most recent follow-up information incorporated above includes: on(b)(6) 2018: this case became potential legal case and device malfunction was added as event. This (b)(6)-year-old female patient used aleve tens device direct therapy unit for sciatica pain and experienced medical device site burn. The event is unlisted in reference safety information for suspect product. Considering probable temporal relationship, relation of the site of application and the electric nature of this device, company cannot exclude causality of suspect product. This case was regarded as incident.
 
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Brand NameALEVE TENS DEVICE DIRECT THERAPY UNIT
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 lamberson
100 bayer blvd.
p.o. box 915
whippany, NJ 07981-0915
MDR Report Key8008538
MDR Text Key125096381
Report Number2248903-2018-00005
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 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1613538
Device Lot NumberT0K6M8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/26/2018 Patient Sequence Number: 1
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