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

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.

Manufacturer Narrative

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 61-year-old female patient who received aleve tens device direct therapy unit (batch no.629503) for pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device issue "aleve tens unit malfunction/ unexpected intensity changes." on an unknown date, the patient started aleve tens device direct therapy unit.On (b)(6) 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.Quality safety evaluation of ptc: based on technical investigation the gel pad lot# 629503 was packaged with the tens device.The dhr (device history record) was reviewed, and no abnormal process conditions were present during the manufacturing of the product.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product met qc (quality control) release specification.Due to that fact that no sample was provided, no complaint trend exists, and a root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness.This complaint will be recorded for tracking and trending purposes.No complaint sample or photos were received for investigation at responsible quality unit (rqu).Investigation of the device history record (dhr) was conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 6-apr-2021: update of ptc event aleve tens unit malfunction to device issue.Added lot# 629503 for the device.Quality-safety evaluation: unconfirmed quality defect.A technical investigation was 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.

Manufacturer Narrative

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 61-year-old female patient who received aleve tens device direct therapy unit (batch no.629503) for pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device issue "aleve tens unit malfunction/ unexpected intensity changes".From 2018 until (b)(6) 2020, the patient received aleve tens device direct therapy unit at an unspecified dose and frequency.On (b)(6) 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.Quality-safety evaluation of ptc: based on technical investigation the gel pad lot# 629503 was packaged with the tens device.The dhr (device history record) was reviewed, and no abnormal process conditions were present during the manufacturing of the product.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product met qc (quality control) release specification.Due to that fact that no sample was provided, no complaint trend exists, and a root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness.This complaint will be recorded for tracking and trending purposes.No complaint sample or photos were received for investigation at responsible quality unit (rqu).Investigation of the device history record (dhr) was conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 2-jun-2021: all required attempt were completed.Case closed.A technical investigation was 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.

• Brand Name: ALEVE TENS DEVICE DIRECT THERAPY UNIT
• Type of Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS)
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 36 columbia rd.; morristown NJ 07960
• MDR Report Key: 11552390
• MDR Text Key: 241753926
• Report Number: 2248903-2021-00001
• Device Sequence Number: 1
• Product Code: NUH
• UDI-Device Identifier: 00325866565044
• UDI-Public: 00325866565044
• Combination Product (y/n): N
• PMA/PMN Number: K152852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• 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 Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1613538
• Device Lot Number: 629503
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR