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

Lot Number 608549

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("device getting hot on one side and smoking, and charred the black pad and the gel pad") in a female patient who received aleve tens device direct therapy unit for back pain.On an unknown date, the patient started aleve tens device direct therapy unit.On an unknown date, the patient experienced device material issue.The reporter commented: i just contacted customer service do to my device getting hot and smoking, luckily i was not burnt.The device just got hot on one side and charred the black pad and the gel pad.I have had this for 3 months without any problems most recent follow-up information incorporated above includes: on 29-nov-2017: upon internal quality review, the reported events were revised to device getting hot on one side and smoking, and charred the black pad and the gel pad.Moreover, case category was updated to incident as there was a potential for harm to the patient if device was attached to the skin.This spontaneous report refers to a female patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) for severe back pain on unspecified dates.Within 3 months of use without any problem, device got hot on one side and smoking, and charred the black pad and the gel pad.Patient was not burnt.The event was considered non-serious and is listed according aleve tens device direct therapy unit.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.However there was a potential for harm to the patient if the device issue happened while it was attached to the skin.Further information was requested.This case was regarded as incident.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("device getting hot on one side and smoking, and charred the black pad and the gel pad") in a female patient who received aleve tens device direct therapy unit (batch no.608549) for back pain.On an unknown date, the patient started aleve tens device direct therapy unit.On an unknown date, the patient experienced device material issue.The reporter commented: i just contacted customer service do to my device getting hot and smoking, luckily i was not burnt.The device just got hot on one side and charred the black pad and the gel pad.I have had this for 3 months without any problems quality-safety evaluation of ptc: based on the technical investigation, a review of the device history for this serial number was conducted and no defects were identified during the manufacture of the device.The device was returned to bayer and passed testing.Regarding the tens gelpads- the customer returned 2 gel pads stuck together in a small zip lock bag.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The investigation team has reviewed the equipment, material and process and the probable root cause of the reported condition as stated by the customer.Visual inspection through the microscope confirmed the electrodes were applied to patients as derma was present.One gel pad had a dark brown area with a small area missing gel with only the scrim present.Within that area there appeared to be some evidence of hardened gel.There was very little "tack" from the gel when touched with a nitrile glove, this is consistent with gel pads that have been used.The reported condition was not confirmed.Through the product analysis of the reported condition as stated by the customer, it has been determined that the probable root cause is not related to the gel pad.No defects were identified all aleve direct therapy tens units 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.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 19-dec-2017: quality-safety evaluation of ptc was received.This spontaneous report refers to a female patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) for severe back pain on unspecified dates.Within 3 months of use without any problem, device got hot on one side and smoking, and charred the black pad and the gel pad.Patient was not burnt.The event was considered non-serious and is listed according aleve tens device direct therapy unit.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.However there was a potential for harm to the patient if the device issue happened while it was attached to the skin.Further information was requested.This case was regarded as incident.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("device getting hot on one side and smoking, and charred the black pad and the gel pad") in a female patient who received aleve tens device direct therapy unit (batch no.608549) for back pain.On an unknown date, the patient started aleve tens device direct therapy unit.On an unknown date, the patient experienced device material issue.The reporter commented: i just contacted customer service do to my device getting hot and smoking, luckily i was not burnt.The device just got hot on one side and charred the black pad and the gel pad.I have had this for 3 months without any problems the list of device similar incidents contains aleve tens device direct therapy unit reports received by bayer coded with the same medra preferred term.In this particular case a search in the database was performed on 20-jun-2018 for the following meddra preferred term: pt device material issue: the analysis in the global safety database revealed 0 cases.Bayer is closely monitoring the benefit-risk profile of aleve tens device direct therapy unit.A recent cumulative review of all available data on leve tens device direct therapy unit has not yielded any new safety signal with regard to these meddra pt.Quality-safety evaluation of ptc: based on the technical investigation, a review of the device history for this serial number was conducted and no defects were identified during the manufacture of the device.The device was returned to bayer and passed testing.Regarding the tens gelpads- the customer returned 2 gel pads stuck together in a small zip lock bag.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The investigation team has reviewed the equipment, material and process and the probable root cause of the reported condition as stated by the customer.Visual inspection through the microscope confirmed the electrodes were applied to patients as derma was present.One gel pad had a dark brown area with a small area missing gel with only the scrim present.Within that area there appeared to be some evidence of hardened gel.There was very little "tack" from the gel when touched with a nitrile glove, this is consistent with gel pads that have been used.The reported condition was not confirmed.Through the product analysis of the reported condition as stated by the customer, it has been determined that the probable root cause is not related to the gel pad.No defects were identified all aleve direct therapy tens units 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.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Further company follow-up with the consumer is not possible.Most recent follow-up information incorporated above includes: on 18-jun-2018: despite follow up attempts no further information could be obtained - case closed this spontaneous report refers to a female patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) for severe back pain on unspecified dates.Within 3 months of use without any problem, device got hot on one side and smoking, and charred the black pad and the gel pad.Patient was not burnt.The event was considered non-serious and is listed according aleve tens device direct therapy unit.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.However there was a potential for harm to the patient if the device issue happened while it was attached to the skin.No further information is expected.This case was regarded as incident.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.

• Brand Name: ALEVE DIRECT THERAPY TENS
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, ELECTRICAL NERVE STIMULATOR (TENS)
• Manufacturer (Section D): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia road; morristown NJ 07960
• MDR Report Key: 7083059
• MDR Text Key: 94282702
• Report Number: 2248903-2017-00002
• 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
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 608549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1