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

Model Number UNKNOWN

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Erythema (1840); Paralysis (1997); Burn, Thermal (2530); Shock from Patient Lead(s) (3162)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of burns third degree ("he believes he has third degree burns even though it has not been verified by hcp") in a (b)(6)-year-old male patient who received aleve tens device direct therapy unit for back pain. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device ineffective "this is supposed to relieve pain not give pain" and device stimulation issue "i was shocked" (seriousness criterion medically significant) over a period of 20 min. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced burns third degree (seriousness criterion medically significant) with erythema and mobility decreased ("the shock caused me to become immobile / loss of movement in right side by shock"). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the burns third degree had not resolved and the mobility decreased had resolved. The reporter considered burns third degree and mobility decreased to be related to aleve tens device direct therapy unit. The reporter commented: that he was about 5 minutes into using the device when he experienced an electrical shock that lasted about 20 minutes or so, it was stinging to the point it felt like it was burning him. The stinging was so excruciating he could not reach the remote to turn it off because of the pain it was giving and immobilized the right side of his body which lasted several minutes before he could use his whole body again. Reporter stated it left red marks where the patch was in my back and he think he has third degree burns even though it has not been verified by an hcp. He used the device several times prior to his experience and never had the events experienced this last time and he has not received medical treatment or is using anything to treat the red marks or the third degree burns. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20. 8 kg/sqm. Most recent follow-up information incorporated above includes: on (b)(4) 2018: following internal review the code of event "the shock caused me to become immobile / loss of movement in right side by shock" was changed from pt "hemiparesthesia" to pt "mobility decreased". On (b)(6) 2018: no new clinical information. On (b)(6) 2018: no new clinical information. This spontaneous report refers to a (b)(6) year-old male patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) since unspecified date (used the device several times) for back pain. Five minutes into using the device, he experienced an electrical shock that lasted about 20 minutes or so, the shock caused him to become immobile / loss of movement in right side by shock (non-serious event upon follow-up). Reporter stated it left red marks where the patch was in his back and he believes he has third degree burns even though it has not been verified by hcp (health care professional). The events are considered serious due to medical importance and are unlisted according to aleve tens reference safety information. This case lacks information for a comprehensive assessment, including intensity after turning the device on, treatment mode when event was experienced and presence of any implantable electric or metallic device. However considering the mechanisms of action of suspect product, the close temporal relationship and the nature of reported event, causal or contributory role of aleve tens to the events cannot be excluded. 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 burns third degree ("he believes he has third degree burns even though it has not been verified by hcp") in a (b)(6)-year-old male patient who received aleve tens device direct therapy unit (batch no. T0dztx) for back pain. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device ineffective "this is supposed to relieve pain not give pain" and device stimulation issue "i was shocked" (seriousness criterion medically significant) over a period of 20 min. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced burns third degree (seriousness criterion medically significant) with erythema and mobility decreased ("the shock caused me to become immobile / loss of movement in right side by shock"). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the burns third degree had not resolved and the mobility decreased had resolved. The reporter considered burns third degree and mobility decreased to be related to aleve tens device direct therapy unit. The reporter commented: that he was about 5 minutes into using the device when he experienced an electrical shock that lasted about 20 minutes or so, it was stinging to the point it felt like it was burning him. The stinging was so excruciating he could not reach the remote to turn it off because of the pain it was giving and immobilized the right side of his body which lasted several minutes before he could use his whole body again. Reporter stated it left red marks where the patch was in my back and he think he has third degree burns even though it has not been verified by an hcp. He used the device several times prior to his experience and never had the events experienced this last time and he has not received medical treatment or is using anything to treat the red marks or the third degree burns. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20. 8 kg/sqm. Quality-safety evaluation of ptc: based on the technical investigation this product technical complaint cannot be confirmed at this time. No product was returned. Good faith attempts were made to retrieve the product; no further information could be obtained. A review of the device history for this serial number was conducted and no defects were identified during the manufacture of the device. 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. 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 21-feb-2018: quality-safety evaluation of ptc. This spontaneous report refers to a (b)(6) year-old male patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) since unspecified date (used the device several times) for back pain. 5 minutes into using the device he experienced an electrical shock that lasted about 20 minutes or so, the shock caused him to become immobile / loss of movement in right side by shock (non-serious event upon follow-up). Reporter stated it left red marks where the patch was in his back and he believes he has third degree burns even though it has not been verified by hcp (health care professional). The events are considered serious due to medical importance and are unlisted according to aleve tens reference safety information. This case lacks information for a comprehensive assessment, including intensity after turning the device on, treatment mode when event was experienced and presence of any implantable electric or metallic device. However considering the mechanisms of action of suspect product, the close temporal relationship and the nature of reported event, causal or contributory role of aleve tens to the events cannot be excluded. Further information was requested. A product technical complaint investigation resulted in an unconfirmed quality defect. This case was regarded as incident.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of burns third degree ("he believes he has third degree burns even though it has not been verified by hcp") in a (b)(6)-year-old male patient who received aleve tens device direct therapy unit for back pain. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device ineffective "this is supposed to relieve pain not give pain" and device stimulation issue "i was shocked" (seriousness criterion medically significant) over a period of 20 min. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced burns third degree (seriousness criterion medically significant) with erythema and mobility decreased ("the shock caused me to become immobile / loss of movement in right side by shock"). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the burns third degree had not resolved and the mobility decreased had resolved. The reporter considered burns third degree and mobility decreased to be related to aleve tens device direct therapy unit. The reporter commented: that he was about 5 minutes into using the device when he experienced an electrical shock that lasted about 20 minutes or so, it was stinging to the point it felt like it was burning him. The stinging was so excruciating he could not reach the remote to turn it off because of the pain it was giving and immobilized the right side of his body which lasted several minutes before he could use his whole body again. Reporter stated it left red marks where the patch was in my back and he think he has third degree burns even though it has not been verified by an hcp. He used the device several times prior to his experience and never had the events experienced this last time and he has not received medical treatment or is using anything to treat the red marks or the third degree burns. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20. 8 kg/sqm. 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-mar-2018 for the following meddra preferred term: burns third degree, the analysis in the global safety database revealed 0 (zero) case(s). Device stimulation issue, the analysis in the global safety database revealed 2 (two) case(s). Bayer is closely monitoring the benefit-risk profile of aleve tens device direct therapy unit. A recent cumulative review of all available data on aleve 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, the tens device was received. No gelpads or gelpad packaging was returned that would identify the gelpad lot number. Based on the technical investigation of the returned device, the product passed all test results and met specifications. 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. 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. Further company follow-up with the consumer is not possible. Most recent follow-up information incorporated above includes: on 16-mar-2018: case closed. Reporter declined to provide further details, or give consent to contact his physician. Most recent follow-up information incorporated above includes: on 28-mar-2018: quality-safety evaluation of ptc: unconfirmed quality defect. Sample was received. This spontaneous report refers to a (b)(6) year-old male patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) since unspecified date (used the device several times) for back pain. 5 minutes into using the device he experienced an electrical shock that lasted about 20 minutes or so, the shock caused him to become immobile / loss of movement in right side by shock (non-serious event upon follow-up). Reporter stated it left red marks where the patch was in his back and he believes he has third degree burns even though it has not been verified by hcp (health care professional). The events are considered serious due to medical importance and are unlisted according to aleve tens reference safety information. This case lacks information for a comprehensive assessment, including intensity after turning the device on, treatment mode when event was experienced and presence of any implantable electric or metallic device. However considering the mechanisms of action of suspect product, the close temporal relationship and the nature of reported event, causal or contributory role of aleve tens to the events cannot be excluded. Further information is not expected. A product technical complaint investigation resulted in an unconfirmed quality defect. This case was regarded as incident.

• 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 rd.; morristown NJ 07960
• Manufacturer (Section G): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia rd.; morristown NJ 07960
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany 07981-0915
• MDR Report Key: 7273682
• Report Number: 2248903-2018-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Age: 30 YR
• Patient Weight: 66
• Patient Outcome(s): Other