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U.S. Department of Health and Human Services

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

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BAYER HEALTHCARE LLC ALEVE DIRECT THERAPY TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) Back to Search Results
Lot Number 609239
Device Problems Improper or Incorrect Procedure or Method (2017); Defective Device (2588); Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)
Patient Problems Burn(s) (1757); Tingling (2171); Burn, Thermal (2530); Electric Shock (2554)
Event Type  Injury  
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who received aleve tens device direct therapy unit for degenerative disc disease. Other product or product use issues identified: device defective "device did not respond to lowering or shutting off / i purchased a defective aleve tens unit" and device use issue "i used aleve tens to treat degenerative disk pain". The patient's concurrent conditions included degenerative disc disease. On an unknown date, the patient started aleve tens device direct therapy unit unk, tiw. On an unknown date, the patient experienced medical device site injury (seriousness criterion medically significant), scar (seriousness criterion medically significant) and paraesthesia (seriousness criterion medically significant). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the medical device site injury outcome was unknown and the scar and paraesthesia had not resolved. The reporter considered medical device site injury, scar and paraesthesia to be related to aleve tens device direct therapy unit. The reporter commented: consumer reported start date for device as over the summer. She reported she used the product approximately 3 times a week until a few months ago. She reported no concomitant product use. Most recent follow-up information incorporated above includes: on 21-mar-2017: following global safety leader review the seriousness and the incident category were amended. Also the case (b)(4) was identified as a duplicate from this case. All the information was transferred to the remaining case: demographic data, indication updated, event terms, outcome and action taken with drug updated. Serial number added. Events "i used aleve tens to treat degenerative disk pain" and "i have tingling sensation on skin where the burn mark used to be" added. Company causality comment: this spontaneous case reported by a consumer described the occurrence of a medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who was using aleve tens device direct therapy unit to treat degenerative disk pain (unapproved indication). These events are serious due to medical importance and unlisted in the reference safety information for aleve tens. Medical events burn, burn marks and paresthesia were reported in association with a device defective (device did not respond to lowering or shutting off / i purchased a defective aleve tens unit). In this context, considering the mechanism of action of device, compatible temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information will be requested.
 
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of electric shock ("aleve tens responded with an electric shock"), medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn / burn caused large markings") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) year-old female patient who received aleve tens device direct therapy unit for degenerative disc disease. Other product or product use issues identified: device defective "device did not respond to lowering or shutting off / i purchased a defective alleve tens unit" and device use issue "i used aleve tens to treat degenerative disk pain". The patient's concurrent conditions included degenerative disc disease since 2002. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced electric shock (seriousness criterion medically significant), medical device site injury (seriousness criterion medically significant), scar (seriousness criterion medically significant) and paraesthesia (seriousness criterion medically significant). The patient was treated with miconazole nitrate (neosporin af). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the electric shock and medical device site injury outcome was unknown, the scar had resolved and the paraesthesia had not resolved. The reporter considered electric shock, medical device site injury, paraesthesia and scar to be related to aleve tens device direct therapy unit. The reporter commented: consumer reported start date for device as over the summer. She reported she used the product approximately 3 times a week until a few months ago. She reported no concomitant product use. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6). Most recent follow-up information incorporated above includes: on 10-apr-2017: patient date of birth changed from (b)(6). The event responded with an electric shock was added. Company causality comment: this spontaneous case reported by a consumer described the occurrence of a aleve tens responded with an electric shock, medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) year-old female patient who was using aleve tens device direct therapy unit to treat degenerative disk pain (unapproved indication). These events are serious due to medical importance and unlisted in the reference safety information for aleve tens. Medical events burn, burn marks and paresthesia were reported in association with a device defective (device did not respond to lowering or shutting off / i purchased a defective aleve tens unit). Patient reported that device did not respond to lowering or shutting off and it responded with an electric shock. In this context, considering the mechanism of action of device, compatible temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information will be requested.
 
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ("cause my back to burn"), medical device site scar ("did leave burn marks / i have a brown stain on back from burn / burn caused large markings") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who received aleve tens device direct therapy unit for degenerative disc disease. Other product or product use issues identified: device use issue "i used aleve tens to treat degenerative disk pain", device defective "device did not respond to lowering or shutting off / i purchased a defective aleve tens unit" and device stimulation issue "aleve tens responded with an electric shock" (seriousness criterion medically significant). The patient's concurrent conditions included degenerative disc disease since 2002. On an unknown date, the patient started aleve tens device direct therapy unit at an unspecified dose 3 times a week. On an unknown date, the patient experienced medical device site burn (seriousness criterion medically significant), medical device site scar (seriousness criterion medically significant) and paraesthesia (seriousness criterion medically significant). The patient was treated with miconazole nitrate (neosporin af). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the medical device site burn outcome was unknown, the medical device site scar had resolved and the paraesthesia had not resolved. The reporter considered medical device site burn, medical device site scar and paraesthesia to be related to aleve tens device direct therapy unit. The reporter commented: consumer reported start date for device as over the summer. She reported she used the product approximately 3 times a week until a few months ago. She reported no concomitant product use. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27. 1 kg/sqm. Quality-safety evaluation of ptc: based on the technical investigation, 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 none identified for the applicable lot. Without a returned sample, no further investigation is possible. This issue will be monitored and trended to potentially identify new failure modes. The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect. This complaint is subject to routine signaling, trending according to established procedures. Any need for a corrective and/or preventive action due to the adverse event is determined in response to the respective signal. Most recent follow-up information incorporated above includes: on 2-may-2017: quality-safety evaluation of ptc. Company causality comment: this spontaneous case reported by a consumer described the occurrence of a aleve tens responded with an electric shock, medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who was using aleve tens device direct therapy unit to treat degenerative disk pain (unapproved indication). These events are serious due to medical importance and unlisted in the reference safety information for aleve tens. Medical events burn, burn marks and paresthesia were reported in association with a device defective (device did not respond to lowering or shutting off / i purchased a defective aleve tens unit). Patient reported that device did not respond to lowering or shutting off and it responded with an electric shock. In this context, considering the mechanism of action of device, compatible temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information will be requested. The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect, final risk category v.
 
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ("cause my back to burn"), medical device site scar ("did leave burn marks / i have a brown stain on back from burn / burn caused large markings") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who received aleve tens device direct therapy unit (batch no. 609239) for degenerative disc disease. Other product or product use issues identified: device use issue "i used aleve tens to treat degenerative disk pain", device defective "device did not respond to lowering or shutting off / i purchased a defective alleve tens unit" and device stimulation issue "aleve tens responded with an electric shock" (seriousness criterion medically significant). The patient's concurrent conditions included degenerative disc disease since 2002. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced medical device site burn (seriousness criterion medically significant), medical device site scar (seriousness criterion medically significant) and paraesthesia (seriousness criterion medically significant). The patient was treated with miconazole nitrate (neosporin af). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the medical device site burn outcome was unknown, the medical device site scar had resolved and the paraesthesia had not resolved. The reporter considered medical device site burn, medical device site scar and paraesthesia to be related to aleve tens device direct therapy unit. The reporter commented: consumer reported start date for device as over the summer. She reported she used the product approximately 3 times a week until a few months ago. She reported no concomitant product use. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6). Quality-safety evaluation of ptc: based on the technical investigation, 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 none identified for the applicable lot. Without a returned sample, no further investigation is possible. This issue will be monitored and trended to potentially identify new failure modes. There were no samples or photographs submitted with this complaint. The product analysis confirmed that the failure contributed to the reportable event is not applicable. It is unable to determine whether the product meets specification and the failure confirmation of the reported condition was unable to confirm. 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 the electrode not placed evenly on the skin or when there is inadequate skin preparation if the product instruction for use (ifu) is not strictly followed. Due to no sample being provided to manufacturing site, a root cause for the reported condition could not be specifically identified. Therefore, corrective action will be limited to the manufacturing awareness. No further corrective action is required at this time. The outcome of the investigation resulted in an unconfirmed quality defect. This complaint is subject to routine signaling, trending according to established procedures. Any need for a corrective and/or preventive action due to the adverse event is determined in response to the respective signal. Most recent follow-up information incorporated above includes: on 12-jun-2017: quality-safety evaluation of ptc: unconfirmed quality defect; lot number was added. Company causality comment: this spontaneous case reported by a consumer described the occurrence of aleve tens responded with an electric shock, medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who was using aleve tens device direct therapy unit to treat degenerative disk pain (unapproved indication). These events are serious due to medical importance and unlisted in the reference safety information for aleve tens. Medical events burn, burn marks and paresthesia were reported in association with a device defective (device did not respond to lowering or shutting off / i purchased a defective aleve tens unit). Patient reported that device did not respond to lowering or shutting off and it responded with an electric shock. In this context, considering the mechanism of action of device, compatible temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information will be requested. The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect, final risk category v.
 
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ("cause my back to burn"), medical device site scar ("did leave burn marks / i have a brown stain on back from burn / burn caused large markings") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who received aleve tens device direct therapy unit for degenerative disc disease. Co-suspect products included aleve tens gel pad (batch no. 609239). Other product or product use issues identified: device use issue "i used aleve tens to treat degenerative disk pain", device defective "device did not respond to lowering or shutting off / i purchased a defective alleve tens unit" and device stimulation issue "aleve tens responded with an electric shock" (seriousness criterion medically significant). The patient's concurrent conditions included degenerative disc disease since 2002. On an unknown date, the patient started aleve tens gel pad. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced medical device site burn (seriousness criterion medically significant), medical device site scar (seriousness criterion medically significant) and paraesthesia (seriousness criterion medically significant). The patient was treated with miconazole nitrate (neosporin af). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the medical device site burn outcome was unknown, the medical device site scar had resolved and the paraesthesia had not resolved. The reporter considered medical device site burn, medical device site scar and paraesthesia to be related to aleve tens device direct therapy unit. The reporter provided no causality assessment for medical device site burn, medical device site scar and paraesthesia with aleve tens gel pad. The reporter commented: consumer reported start date for device as over the summer. She reported she used the product approximately 3 times a week until a few months ago. She reported no concomitant product use. Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6). Quality-safety evaluation of ptc for aleve tens device direct therapy unit from 11-jul-2017: batch documentation has been reviewed for aleve tens device and gel pads. All deviations and non-conformances have also been reviewed by bayer quality assurance to identify potential product quality concerns, with none identified for the applicable lot. The purported device was not returned for evaluation. Without a returned sample, no further investigation is possible. This issue will be monitored and trended to potentially identify new failure modes. The outcome of the investigation resulted in an unconfirmed quality defect. This complaint is subject to routine signaling, trending according to established procedures. Any need for a corrective and/or preventive action due to the adverse event is determined in response to the respective signal. Most recent follow-up information incorporated above includes: on 11-jul-2017: quality-safety evaluation of ptc for aleve tens device direct therapy unit: unconfirmed quality defect. Upon receipt of ptc investigation results, the suspect drug aleve tens gel pad was added for the lot number 609239. Company causality comment: this spontaneous case reported by a consumer described the occurrence of aleve tens responded with an electric shock, medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who was using aleve tens device direct therapy unit and aleve tens gel pad to treat degenerative disk pain (unapproved indication). These events are serious due to medical importance and unlisted in the reference safety information for aleve tens. Medical events burn, burn marks and paresthesia were reported in association with a device defective (device did not respond to lowering or shutting off / i purchased a defective aleve tens unit). Patient reported that device did not respond to lowering or shutting off and it responded with an electric shock. In this context, considering the mechanism of action of device, compatible temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information will be requested. This case was regarded as other reportable incident. The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect, final risk category v.
 
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Brand NameALEVE DIRECT THERAPY TENS
Type of DeviceTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS)
Manufacturer (Section D)
BAYER HEALTHCARE LLC
3030 jackson avenue
memphis TN 38151
Manufacturer (Section G)
BAYER HEALTHCARE LLC
3030 jackson avenue
memphis TN 38151
Manufacturer Contact
k. shaw lamberson
100 bayer blvd, p o box 915
whippany, NJ 07981-0915
MDR Report Key6457545
MDR Text Key71678278
Report Number1020060-2017-00005
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,Followup,Followup,Followup
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Lot Number609239
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
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