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U.S. Department of Health and Human Services

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

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BAYER HEALTHCARE LLC, CONSUMER CARE ALEVE DIRECT THERAPY TENS STIMULATOR, NERVE, TRANSCUTANEOUS, ELECTRICAL NERVE STIMULATOR (TENS) Back to Search Results
Model Number 1613538
Device Problem Gel Leak (1267)
Patient Problems Therapeutic Effects, Unexpected (2099); Caustic/Chemical Burns (2549)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of first degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns"), second degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") and third degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") in a male patient who received aleve tens device direct therapy unit (batch no. Unk). Other product or product use issues identified: device leakage "he said that whatever is in the gel that leaked out must have reacted with my skin," in 2016, contraindicated device used "titanium plates as well as a ton of rods and screws on lower back" and therapeutic response unexpected "the unit had helped me reduce my opioid use". The patient's concurrent conditions included spinal fusion nos since 2014 and internal fixation of spine. On an unknown date, the patient started aleve tens device direct therapy unit. In 2016, the patient experienced first degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, pruritus and skin ulcer, second degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, pruritus and skin ulcer and third degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, pruritus, scab and skin ulcer. The patient was treated with neosporin (neosporin topical). Aleve tens device direct therapy unit was interrupted. At the time of the report, the first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin had resolved. The reporter considered first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin to be related to aleve tens device direct therapy unit. The reporter commented: i replaced the pads for about the 10th time, put them on and laid down. I had it on level 3 or 4, not to high, and the events occurred. Consumer used the product before for about 3 months with no issues. Quality-safety evaluation of ptc: (b)(4): unconfirmed quality defect: risk category v. Per global sop 115, if no sample are available and no batch data of the medical product or medical device have been reported in the complaint, it is closed without further investigation. A ptc investigation can not be initiated as a batch number or sample was not provided thus resulting in an unconfirmed quality defect. (b)(4): unconfirmed quality defect: risk category v. Batch documentation has been reviewed by bayer quality assurance. All deviations and non-conformances have also been reviewed by bayer quality assurance to identify potential product quality concerns, with non identified for the applicable lot. Without a return sample, no further investigation is possible. This issue will be monitored and treated to potentially identify new failure modes. Based on the information available, batch documentation was received and no product quality concerns were identified, however, since no sample was provided no final assessment is possible thus resulting in an outcome of unconfirmed quality defect. Most recent follow-up information incorporated above includes: on 27-jun-2017: the previously reported event they looked like chemical burns/ they looked like burns/the burn was very bad was reworked to they looked like chemical burns/ they looked like burns/the burn was very bad /they were first, second and third degree burns and open sores on back and itching on sores were added as symptom for this event; event titanium plates as well as a ton of rods and screws on lower back was also added; medical history updated. Company causality comment: this spontaneous case, reported by a consumer, describes the occurrence of serious events chemical injury- first degree burns, second degree burns and third degree burns ("they looked like chemical burns/ they looked like burns/the burn was very bad") (medically significant and intervention required) in a male patient who received aleve tens device direct therapy unit for a not reported indication. This events are unlisted according to aleve tens reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens cannot be excluded, in agreement with reporter. Ptc investigation: unconfirmed quality defect.
 
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of first degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns"), second degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") and third degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") in a male patient who received aleve tens device direct therapy unit. Co-suspect products included aleve tens gel pad (batch no. (b)(4)). Other product or product use issues identified: device leakage "he said that whatever is in the gel that leaked out must have reacted with my skin," in 2016, medical device monitoring error "titanium plates as well as a ton of rods and screws on lower back", therapeutic response unexpected "the unit had helped me reduce my opioid use", product quality issue "gelpad melted" and contraindicated device used "titanium plates as well as a ton of rods and screws on lower back". The patient's concurrent conditions included spinal fusion nos since 2014 and internal fixation of spine. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient started aleve tens gel pad. In 2016, the patient experienced first degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, wound complication and skin ulcer, second degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, wound complication and skin ulcer and third degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, wound complication, scab and skin ulcer. The patient was treated with neosporin (neosporin topical). Aleve tens device direct therapy unit was interrupted. At the time of the report, the first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin had resolved. The reporter considered first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin to be related to aleve tens device direct therapy unit and aleve tens gel pad. The reporter commented: i replaced the pads for about the 10th time, put them on and laid down. I had it on level 3 or 4, not to high, and the events occurred. Consumer used the product before for about 3 months with no issues. Based on the returned gel pad product samples, aleve tens gel pads was added as co-suspect; the gel pad melted was added as new event. Gel pad lot # 612622. Product was used on lower back. It was unknown if the gelpads were from the original kit or replacements; it was also unknown whether patient read the user manual, or if the original batteries were not used, or if gel pads stored improperly. Quality-safety evaluation of ptc: based on the technical investigation for aleve tens device, no product was returned and no product identification information such as serial # was provided where a complaint investigation or device history record review can be performed. 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 to ensure all released product meets product specifications. An in depth ptc investigation cannot be conducted by the quality unit as a serial number or sample was not provided. The quality unit evaluation was unable to confirm the complaint. Most recent follow-up information incorporated above includes: on 2-aug-2017: quality-safety evaluation of ptc. This spontaneous case, reported by a consumer, describes the occurrence of serious events chemical injury- first degree burns, second degree burns and third degree burns ("they looked like chemical burns/ they looked like burns/the burn was very bad") (medically significant and intervention required) in a male patient who received aleve tens device direct therapy unit and aleve tens gel pad for a not reported indication. These events are unlisted according to aleve tens device direct therapy and aleve tens gel pad reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens device direct therapy and aleve tens gel pad cannot be excluded, in agreement with reporter. Ptc investigation: unconfirmed quality defect.
 
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of first degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns"), second degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") and third degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") in a male patient who received aleve tens device direct therapy unit. Co-suspect products included aleve tens gel pad (batch no. 612622). Other product or product use issues identified: device leakage "he said that whatever is in the gel that leaked out must have reacted with my skin," in 2016, medical device monitoring error "titanium plates as well as a ton of rods and screws on lower back", device material issue "gelpad melted", contraindicated device used "titanium plates as well as a ton of rods and screws on lower back" and therapeutic response unexpected "the unit had helped me reduce my opioid use". The patient's concurrent conditions included spinal fusion nos since 2014 and internal fixation of spine. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient started aleve tens gel pad. In 2016, the patient experienced first degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, wound complication and skin ulcer, second degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, wound complication and skin ulcer and third degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, wound complication, scab and skin ulcer. The patient was treated with neosporin (neosporin topical). Aleve tens device direct therapy unit was interrupted. At the time of the report, the first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin had resolved. The reporter considered first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin to be related to aleve tens device direct therapy unit and aleve tens gel pad. No further causality assessment were provided for the product. The reporter commented: i replaced the pads for about the 10th time, put them on and laid down. I had it on level 3 or 4, not to high, and the events occurred. Consumer used the product before for about 3 months with no issues. Based on the returned gel pad product samples, aleve tens gel pads was added as co-suspect; the gel pad melted was added as new event. Gel pad lot # 612622. Product was used on lower back. It was unknown if the gelpads were from the original kit or replacements; it was also unknown whether patient read the user manual, or if the original batteries were not used, or if gel pads stored improperly. Quality-safety evaluation of ptc: based on the technical investigation for aleve tens device, no product was returned and no product identification information such as serial # was provided where a complaint investigation or device history record review can be performed. 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 to ensure all released product meets product specifications. An in depth ptc investigation cannot be conducted by the quality unit as a serial number or sample was not provided. The quality unit evaluation was unable to confirm the complaint. Most recent follow-up information incorporated above includes: on 25-aug-2017: aleve tens serial number was provided (b)(4), model number: 1613538 and additional aleve gel pad lot number (634424), expiration date is 01-dec-2018. This spontaneous case, reported by a consumer, describes the occurrence of serious events chemical injury- first degree burns, second degree burns and third degree burns ("they looked like chemical burns/ they looked like burns/the burn was very bad") (medically significant and intervention required) in a male patient who received aleve tens device direct therapy unit and aleve tens gel pad for a not reported indication. These events are unlisted according to aleve tens device direct therapy and aleve tens gel pad reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens device direct therapy and aleve tens gel pad cannot be excluded, in agreement with reporter. These events were regarded as incidents. Ptc investigation: unconfirmed quality defect.
 
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of first degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns"), second degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") and third degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") in a male patient who received aleve tens device direct therapy unit. Co-suspect products included aleve tens gel pad (batch no. 612622). Other product or product use issues identified: device leakage "he said that whatever is in the gel that leaked out must have reacted with my skin," in 2016, medical device monitoring error "titanium plates as well as a ton of rods and screws on lower back", device material issue "gelpad melted", contraindicated device used "titanium plates as well as a ton of rods and screws on lower back" and therapeutic response unexpected "the unit had helped me reduce my opioid use". The patient's concurrent conditions included spinal fusion nos since 2014 and internal fixation of spine. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient started aleve tens gel pad. In 2016, the patient experienced first degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, wound complication and skin ulcer, second degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, wound complication and skin ulcer and third degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, wound complication, scab and skin ulcer. The patient was treated with neosporin (neosporin topical). Aleve tens device direct therapy unit was interrupted. At the time of the report, the first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin had resolved. The reporter considered first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin to be related to aleve tens device direct therapy unit and aleve tens gel pad. The reporter commented: i replaced the pads for about the 10th time, put them on and laid down. I had it on level 3 or 4, not to high, and the events occurred. Consumer used the product before for about 3 months with no issues. Based on the returned gel pad product samples, aleve tens gel pads was added as co-suspect; the gel pad melted was added as new event. Gel pad lot # 612622. Product was used on lower back. It was unknown if the gelpads were from the original kit or replacements; it was also unknown whether patient read the user manual, or if the original batteries were not used, or if gel pads stored improperly. Quality-safety evaluation of ptc: based on the technical investigation of aleve tens unit, an investigation of the reported condition was performed on the aleve tens direct therapy device which was returned by the consumer. Electrical evaluation of the returned sample was unable to confirm any failure modes related to the reported condition. Aleve direct therapy tens units are made in accordance with current good manufacturing practices and to the applicable fda and iso regulations. All products 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. Since a root cause for the reported condition cannot be identified, corrective action will be limited to the manufacturing awareness. No further corrective action is required at this time. This issue will be monitored and trended to potentially identify new failure modes. The ptc investigation was conducted and the outcome of the investigation resulted in an unconfirmed quality defect. Based on the technical investigation of aleve tens gel pads with lot # 612622, from the returned samples, the product analysis was unable to confirm the failure of the reported condition. The returned gel pads appeared to be well used. There were no indications the electrodes were not manufactured properly during the visual inspection. The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. The investigation determined that the most probable root cause is due to not placing the electrode evenly on the skin or when there is inadequate skin preparation. It is important that proper customer preparation techniques be completed which specify wash the skin and dry completely. One of the contributing factors is not properly storing the gel pads. It should be applied to the gel pad before storage and avoid temperature extremes above 104 degree f and below 50 degree f. The other contributing factor is the customer skin types, oils, and ph levels can impact the usage of the pads 2-5 applications. Due to that fact that a root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness. 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 5-feb-2018: reporter did not respond to final follow up attempt, consider case closed. This spontaneous case, reported by a consumer, describes the occurrence of serious events chemical injury- first degree burns, second degree burns and third degree burns ("they looked like chemical burns/ they looked like burns/the burn was very bad") (medically significant and intervention required) in a male patient who received aleve tens device direct therapy unit and aleve tens gel pad for a not reported indication. These events are unlisted according to aleve tens device direct therapy and aleve tens gel pad reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens device direct therapy and aleve tens gel pad cannot be excluded, in agreement with reporter. These events were regarded as incidents. Ptc investigation: unconfirmed quality defect.
 
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of chemical injury ("they looked like chemical burns/ they looked like burns/the burn was very bad") in a male patient who received aleve tens device direct therapy unit. Other product or product use issues identified: device leakage "he said that whatever is in the gel that leaked out must have reacted with my skin," and therapeutic response unexpected "the unit had helped me reduce my opioid use". The patient's concurrent conditions included spinal fusion nos. On an unknown date, the patient started aleve tens device direct therapy unit at an unspecified dose and frequency. In 2016, the patient experienced chemical injury (seriousness criteria medically significant and clinically significant/intervention required) with urticaria and scab. The patient was treated with neosporin (neosporin topical). Aleve tens device direct therapy unit was interrupted. At the time of the report, the chemical injury outcome was unknown. The reporter considered chemical injury to be related to aleve tens device direct therapy unit. The reporter commented: i replaced the pads for about the 10th time, put them on and laid down. I had it on level 3 or 4, not to high, and the events occurred. Quality-safety evaluation of ptc: (b)(4): unconfirmed quality defect: risk category v. Final assessment: per global (b)(4), if no sample are available and no batch data of the medical product or medical device have been reported in the complaint, it is closed without further investigation. Medical assessment: a ptc investigation can not be initiated as a batch number or sample was not provided thus resulting in an unconfirmed quality defect. (b)(4): unconfirmed quality defect: risk category v. Final assessment : batch documentation has been reviewed by bayer quality assurance. All deviations and non-conformances have also been reviewed by bayer quality assurance to identify potential product quality concerns, with non identified for the applicable lot. Without a return sample, no further investigation is possible. This issue will be monitored and treated to potentially identify new failure modes. Medical assessment: based on the information available, batch documentation was received and no product quality concerns were identified, however, since no sample was provided no final assessment is possible thus resulting in an outcome of unconfirmed quality defect. Most recent follow-up information incorporated above includes: on 1-mar-2017: ptc investigation result received. Unconfirmed quality defect: risk category v. Company causality comment: this spontaneous case, reported by a consumer,describes the occurrence of serious event chemical injury ("they looked like chemical burns/ they looked like burns/the burn was very bad")(medically significant and intervention required ) in a male patient who received aleve tens device direct therapy unit for a not reported indication. This event is unlisted according to aleve tens reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens cannot be excluded, in agreement with reporter.
 
Event Description
Most recent follow-up information incorporated above includes: on 28-feb-2017: quality safety evaluation: unconfirmed quality defect: risk category v. Company causality comment: this spontaneous case, reported by a consumer,describes the occurrence of serious event chemical injury ("they looked like chemical burns/ they looked like burns/the burn was very bad")(medically significant and intervention required ) in a male patient who received aleve tens device direct therapy unit for a not reported indication. This event is unlisted according to aleve tens reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens cannot be excluded, in agreement with reporter. Ptc investigation: unconfirmed quality defect.
 
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Brand NameALEVE DIRECT THERAPY TENS
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, ELECTRICAL NERVE STIMULATOR (TENS)
Manufacturer (Section D)
BAYER HEALTHCARE LLC, CONSUMER CARE
36 columbia rd.
morristown NJ 07960
MDR Report Key6373325
MDR Text Key117963057
Report Number1020060-2017-00003
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
PMA/PMN Number
K152852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1613538
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1
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