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

Model Number 1613538

Device Problems Off-Label Use (1494); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Unintended Electrical Shock (4018)

Patient Problems Burn(s) (1757); Pain (1994); Skin Erosion (2075)

Event Date 08/09/2018

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of application site erosion ("top layer of skin is missing on my back") and application site burn ("it burned my back") in a (b)(6) female patient who received aleve tens device direct therapy unit (batch no.625302) for low back pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device stimulation issue "the device shocked me/ output surged so strongly" (seriousness criterion medically significant) on (b)(6) 2018, contraindicated device used "used aleve tens with history of metal knee replacement" and medical device monitoring error "used aleve tens with history of metal knee replacement".The patient's past medical history included knee arthroplasty in 2015.Concurrent conditions included spinal column stenosis and arthritis.Concomitant products included acetylsalicylic acid (aspirin) and paracetamol (tylenol) for pain.On an unknown date, the patient started aleve tens device direct therapy unit.On the same day, the patient experienced application site erosion (seriousness criterion medically significant), application site burn (seriousness criterion medically significant), application site dryness ("my skin is really dry now"), application site pain ("it hurts to touch my skin") and application site exfoliation ("my skin is peeling/ my skin is flaking off").The patient was treated with cortisone.At the time of the report, the application site erosion, application site burn, application site dryness, application site pain and application site exfoliation was resolving.The reporter considered application site burn, application site dryness, application site erosion, application site exfoliation and application site pain to be related to aleve tens device direct therapy unit.The reporter commented: patient said that output was surging from the entire device and it surged so strongly.Patient reported that she couldn't see her back but had her friend look and that was how she knew it was burnt.She had a knee replacement but she did not believe the metal knee replacement would have caused this problem but was not sure.She did not seek medical attention.Patient said that she felt an actual shock, it felt like she put her finger in a light socket patient did not read the user manual.She used the aleve gel pads (new out of box) and it fully covered the black electrode area.She did not use any lubricant or foreign substances on gel pads or her back.Original batteries were used and there was not damage to the device.It was not her first time using the device (she did not know how many prior number of uses she had), and said she had similar issue during previous use.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.9 kg/sqm.The serious events in this case are unlisted in the reference safety information for aleve tens.Use of aleve tens with a history of metal knee replacement may have hypothetically led to an electrical current overflow.Given the electrical nature of this product, company therefore cannot exclude a possible causality and assesses events as related to aleve tens.This case was regarded as an incident.A ptc investigation is underway, and further information is expected.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of application site erosion ("top layer of skin is missing on my back") and application site burn ("it burned my back") in a 75-year-old female patient who received aleve tens device direct therapy unit (batch no.625302) for low back pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device stimulation issue "the device shocked me/ output surged so strongly" (seriousness criterion medically significant) on (b)(6) 2018, medical device monitoring error "used aleve tens with history of metal knee replacement" and contraindicated device used "used aleve tens with history of metal knee replacement".The patient's medical history included knee arthroplasty in 2015.Concurrent conditions included spinal column stenosis and arthritis.Concomitant products included acetylsalicylic acid (aspirin) and paracetamol (tylenol) for pain.On (b)(6) 2018, the patient received aleve tens device direct therapy unit, a few minutes.On (b)(6) 2018, the patient experienced application site erosion (seriousness criterion medically significant), application site burn (seriousness criterion medically significant), application site dryness ("my skin is really dry now"), application site pain ("it hurts to touch my skin") and application site exfoliation ("my skin is peeling/ my skin is flaking off").The patient was treated with cortisone.At the time of the report, the application site erosion, application site burn, application site dryness, application site pain and application site exfoliation was resolving.The reporter considered application site burn, application site dryness, application site erosion, application site exfoliation and application site pain to be related to aleve tens device direct therapy unit.The reporter commented: patient said that output was surging from the entire device and it surged so strongly.Patient reported that she couldn't see her back but had her friend look and that was how she knew it was burnt.She had a knee replacement but she did not believe the metal knee replacement would have caused this problem but was not sure.She did not seek medical attention.Patient said that she felt an actual shock, it felt like she put her finger in a light socket patient did not read the user manual.She used the aleve gel pads (new out of box) and it fully covered the black electrode area.She did not use any lubricant or foreign substances on gel pads or her back.Original batteries were used and there was not damage to the device.It was not her first time using the device (she did not know how many prior number of uses she had), and said she had similar issue during previous use.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.9 kg/sqm.Quality-safety evaluation of ptc: based on the technical investigation the purported device was returned to bayer.All deviations and non-conformances have also been reviewed by bayer quality assurance to identify potential product quality concerns, with none identified for any released lot.A review of the device history for this serial number was conducted and no defects were identified during the manufacture of the device the returned unit was tested and no defects were identified.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.The ptc investigation was conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 11-dec-2018: the product technical complaint investigation was conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Sample was provided for evaluation.We received a serial number ((b)(4)) and returned sample 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.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of application site erosion ("top layer of skin is missing on my back") and application site burn ("it burned my back") in a 75-year-old female patient who received aleve tens device direct therapy unit (batch no.625302) for low back pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device stimulation issue "the device shocked me/ output surged so strongly" (seriousness criterion medically significant) on (b)(6) 2018, medical device monitoring error "used aleve tens with history of metal knee replacement" and contraindicated device used "used aleve tens with history of metal knee replacement".The patient's past medical history included knee arthroplasty in 2015.Concurrent conditions included spinal column stenosis and arthritis.Concomitant products included acetylsalicylic acid (aspirin) and paracetamol (tylenol) for pain.From (b)(6) 2018, the patient received aleve tens device direct therapy unit, a few minutes.On (b)(6) 2018, the patient experienced application site erosion (seriousness criterion medically significant), application site burn (seriousness criterion medically significant), application site dryness ("my skin is really dry now"), application site pain ("it hurts to touch my skin") and application site exfoliation ("my skin is peeling/ my skin is flaking off").The patient was treated with cortisone.At the time of the report, the application site erosion, application site burn, application site dryness, application site pain and application site exfoliation was resolving.The reporter considered application site burn, application site dryness, application site erosion, application site exfoliation and application site pain to be related to aleve tens device direct therapy unit.The reporter commented: patient said that output was surging from the entire device and it surged so strongly.Patient reported that she couldn't see her back but had her friend look and that was how she knew it was burnt.She had a knee replacement but she did not believe the metal knee replacement would have caused this problem but was not sure.She did not seek medical attention.Patient said that she felt an actual shock, it felt like she put her finger in a light socket patient did not read the user manual.She used the aleve gel pads (new out of box) and it fully covered the black electrode area.She did not use any lubricant or foreign substances on gel pads or her back.Original batteries were used and there was not damage to the device.It was not her first time using the device (she did not know how many prior number of uses she had), and said she had similar issue during previous use.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.9 kg/sqm.Most recent follow-up information incorporated above includes: on 3-oct-2018: device return received from patient.Model number added (1613538).The serious events in this case are unlisted in the reference safety information for aleve tens.Use of aleve tens with a history of metal knee replacement may have hypothetically led to an electrical current overflow.Given the electrical nature of this product, company therefore cannot exclude a possible causality and assesses events as related to aleve tens.This case was regarded as an incident.A ptc investigation is underway, and further information is expected.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of application site erosion ("top layer of skin is missing on my back") and application site burn ("it burned my back") in a 75-year-old female patient who received aleve tens device direct therapy unit (batch no.625302) for low back pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device stimulation issue "the device shocked me/ output surged so strongly" (seriousness criterion medically significant) on (b)(6) 2018, medical device monitoring error "used aleve tens with history of metal knee replacement" and contraindicated device used "used aleve tens with history of metal knee replacement".The patient's medical history included knee arthroplasty in 2015.Concurrent conditions included spinal column stenosis and arthritis.Concomitant products included acetylsalicylic acid (aspirin) and paracetamol (tylenol) for pain.On an unknown date, the patient started aleve tens device direct therapy unit.On (b)(6)2018, the patient experienced application site erosion (seriousness criterion medically significant), application site burn (seriousness criterion medically significant), application site dryness ("my skin is really dry now"), application site pain ("it hurts to touch my skin") and application site exfoliation ("my skin is peeling/ my skin is flaking off").The patient was treated with cortisone.At the time of the report, the application site erosion, application site burn, application site dryness, application site pain and application site exfoliation was resolving.The reporter considered application site burn, application site dryness, application site erosion, application site exfoliation and application site pain to be related to aleve tens device direct therapy unit.The reporter commented: patient said that output was surging from the entire device and it surged so strongly.Patient reported that she couldn't see her back but had her friend look and that was how she knew it was burnt.She had a knee replacement but she did not believe the metal knee replacement would have caused this problem but was not sure.She did not seek medical attention.Patient said that she felt an actual shock, it felt like she put her finger in a light socket.Patient did not read the user manual.She used the aleve gel pads (new out of box) and it fully covered the black electrode area.She did not use any lubricant or foreign substances on gel pads or her back.Original batteries were used and there was not damage to the device.It was not her first time using the device (she did not know how many prior number of uses she had), and said she had similar issue during previous use.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.9 kg/sqm.Quality-safety evaluation of ptc: based on the technical investigation the purported device was returned to bayer.All deviations and non-conformances have also been reviewed by bayer quality assurance to identify potential product quality concerns, with none identified for any released lot.A review of the device history for this serial number was conducted and no defects were identified during the manufacture of the device the returned unit was tested and no defects were identified.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.The ptc investigation was conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 12-feb-2019: case closed.We received a serial number ((b)(4)) and returned sample 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.

• Brand Name: ALEVE TENS DEVICE DIRECT THERAPY UNIT
• 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 Key: 7812323
• MDR Text Key: 118099749
• Report Number: 2248903-2018-00004
• Device Sequence Number: 1
• Product Code: NUH
• 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,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2018
• Device Model Number: 1613538
• Device Lot Number: 625302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Date Manufacturer Received: 02/12/2019
• Patient Sequence Number: 1
• Treatment: 1) TYLENOL.; 2) ASPIRIN.; ASPIRIN (ACETYLSALICYLIC ACID).; ASPIRIN (ACETYLSALICYLIC ACID).; ASPIRIN (ACETYLSALICYLIC ACID).; TYLENOL [PARACETAMOL] (PARACETAMOL).; TYLENOL [PARACETAMOL] (PARACETAMOL).; TYLENOL [PARACETAMOL] (PARACETAMOL).; ASPIRIN (ACETYLSALICYLIC ACID); TYLENOL [PARACETAMOL] (PARACETAMOL)
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 67