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

Lot Number 608548

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Electric Shock (2554)

Event Date 10/28/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of electric shock ("this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him") in a (b)(6) male patient who received aleve tens device direct therapy unit (batch no.T02r6x) for pain.The occurrence of additional non-serious events is detailed below.Medical conditions: consumer stated he does not have metal in him and had no phone or metal on him while using the device.Concomitant products included ibuprofen.On an unknown date, the patient started aleve tens device direct therapy unit unk unk, tid.On (b)(6) 2016, the patient experienced electric shock (seriousness criterion medically significant), medical device site injury ("i have a burn mark where this device was"), medical device site pain ("his hurt really bad.") and medical device site erythema ("i have a red mark where the device was").Aleve tens device direct therapy unit was withdrawn.At the time of the report, the electric shock outcome was unknown and the medical device site injury, medical device site pain and medical device site erythema had not resolved.The reporter considered electric shock, medical device site pain and medical device site erythema to be related to aleve tens device direct therapy unit.The reporter provided no causality assessment for medical device site injury with aleve tens device direct therapy unit.Quality-safety evaluation of ptc: batch documentation has been reviewed by bayer quality assurance for all released lots.All deviations and non-conformances have also been reviewed by bayerquality assurance to identify potential product quality concerns.Without a returned sample, no further investigation is possible.This issue will be monitored and trended to potentially identify new failure modes.A ptc investigation cannot be initiated as a batch number or sample was not provided thus resulting in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 22-feb-2017: correction: the event this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him was recoded and case was upgraded.Incident category was updated.Company causality comment: this spontaneous case was reported by a consumer and describes the occurrence of electric shock ("this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him") in a (b)(6) male patient who received aleve tens device direct therapy unit for pain.This event was considered serious as medically important and unlisted according to aleve tens reference safety information.Consumer stated he does not have metal in him and had no phone or metal on him while using the device.Considering the mechanism of action of device and implied temporal relationship, company does not exclude causality between event and suspect device.Further information will be requested.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ("i have a burn mark where this device was"), medical device site pain ("his hurt really bad.") and medical device site erythema ("i have a red mark where the device was") in a (b)(6) year-old male patient who received aleve tens device direct therapy unit (batch no.608548) for pain.Other product or product use issues identified: device stimulation issue "this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him" (seriousness criterion medically significant) on (b)(6) 2016.Medical conditions: consumer stated he does not have metal in him and had no phone or metal on him while using the device.Concomitant products included ibuprofen.On an unknown date, the patient started aleve tens device direct therapy unit.On (b)(6) 2016, the patient experienced medical device site burn, medical device site pain and medical device site erythema.Aleve tens device direct therapy unit was withdrawn.At the time of the report, the medical device site burn, medical device site pain and medical device site erythema had not resolved.The reporter provided no causality assessment for medical device site burn with aleve tens device direct therapy unit.The reporter considered medical device site erythema and medical device site pain to be related to aleve tens device direct therapy unit.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.Quality-safety evaluation of ptc: device batch documentation has been reviewed by bayer quality assurance.All deviations and non-conformance's have also been reviewed by bayer quality assurance to identify potential product quality concerns, with none identified for the applicable lot.Without a returned device, no further investigation is possible.This issue will be monitored and trended to potentially identify new failure modes.An in depth ptc investigation cannot be conducted by the quality unit as a sample was not provided.The quality unit evaluation was unable to confirm the complaint.Most recent follow-up information incorporated above includes: on 11-oct-2017: quality-safety evaluation result of ptc.This spontaneous case was reported by a consumer and describes the occurrence of electric shock ("this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him") in a (b)(6) year-old male patient who received aleve tens device direct therapy unit for pain.This event was considered serious as medically important and unlisted according to aleve tens reference safety information.Consumer stated he does not have metal in him and had no phone or metal on him while using the device.Considering the mechanism of action of device and implied temporal relationship, company does not exclude causality between event and suspect device.

• Brand Name: ALEVE DIRECT THERAPY TENS
• Type of Device: TRANSCUTANEOUS 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 Key: 6373420
• MDR Text Key: 68963875
• Report Number: 1020060-2017-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 608548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 10/30/2017
• 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 Sequence Number: 1
• Treatment: IBUPROFEN (IBUPROFEN [IBUPROFEN])
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 68