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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 T050HL, R05Y64
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Burn, Thermal (2530)
Event Date 01/21/2017
Event Type  Injury  
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit (batch no. T050hl) for pain. The occurrence of additional non-serious events is detailed below. Co-suspect products included aleve tens gel pad. Other product or product use issues identified: therapeutic response unexpected "this helped my back pain from an injury", device use issue "i used this to help a back injury" and device use issue "i used this everyday for 3-4 weeks". Medical conditions: the patient saw a pharmacist who gave him an hydro cream. Concurrent conditions included iodine allergy, seafood allergy and back injury. Concomitant products included cardiovascular system drugs (blood pressure medication (nos)). On an unknown date, the patient started aleve tens device direct therapy unit and aleve tens gel pad. On (b)(6) 2017, the patient experienced medical device site injury (seriousness criteria medically significant and clinically significant/intervention required), medical device site vesicles (seriousness criteria medically significant and clinically significant/intervention required) and medical device site discomfort ("this felt a stronger on my back"). Aleve tens device direct therapy unit was withdrawn. Aleve tens gel pad was withdrawn. At the time of the report, the medical device site injury and medical device site vesicles was resolving and the medical device site discomfort outcome was unknown. The reporter considered medical device site injury, medical device site vesicles and medical device site discomfort to be related to aleve tens device direct therapy unit and aleve tens gel pad. Most recent follow-up information incorporated above includes: on (b)(6) 2017: the events my skin looks burned where the unit was and caused severe burns on my back were combined. The events i have blisters where the unit was and caused blisters on my back were combined. Both events were considered serious and case was upgraded. Incident category was updated. Company causality comment: this spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit / aleve tens gel pad for pain due to back injury (unapproved indication). The events are considered serious due to medical importance and intervention required and are unlisted in the reference safety information for aleve tens. The patient's concurrent conditions included back injury and allergy to iodine and sea food. Consumer had been using the device for about one month with good results and no other problem when he had the events. Patient visited a pharmacist who gave him hydro cream and the burns and vesicles were recovering. In this context, considering the close temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information will be requested.
 
Manufacturer Narrative
Most recent follow-up information incorporated above includes: on 13-mar-2017: lot number for tens device product was deleted and amended to serial number ((b)(4)). Company causality comment: this spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit / aleve tens gel pad for pain due to back injury (unapproved indication). The events are considered serious due to medical importance and intervention required and are unlisted in the reference safety information for aleve tens. The patient's concurrent conditions included back injury and allergy to iodine and seafood. Consumer had been using the device for about one month with good results and no other problem when he had the events. Patient visited a pharmacist who gave him hydro cream and the burns and vesicles were recovering. In this context, considering the close temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information has been requested.
 
Manufacturer Narrative
In (b)(6) 2016, the patient started aleve tens device direct therapy unit at an unspecified dose and frequency and aleve tens gel pad at an unspecified dose and frequency. On (b)(6) 2017, the patient experienced medical device site injury (seriousness criteria medically significant and clinically significant/intervention required), medical device site vesicles (seriousness criteria medically significant and clinically significant/intervention required) and medical device site discomfort ("this felt a stronger on my back"). Aleve tens device direct therapy unit was withdrawn. Aleve tens gel pad was withdrawn. At the time of the report, the medical device site injury and medical device site vesicles was resolving and the medical device site discomfort outcome was unknown. The reporter considered medical device site injury, medical device site vesicles and medical device site discomfort to be related to aleve tens device direct therapy unit and aleve tens gel pad. Quality-safety evaluation of ptc: quality safety evaluation of ptc. Unconfirmed quality defect. 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 foc the applicable lot without a returned sample, no further investigation is possible. This issue will he monitored and trended to potentially identify new failure modes. A ptc technical batch investigation was initiated but since no sample was provided no final assessment is possible thus resulting in an outcome of unconfirmed quality defect. Quality safety evaluation of ptc. Unconfirmed quality defect. If no samples are available and no batch data of the medicinal product or medical device have been reported in the closed without further investigation. Most recent follow-up information incorporated above includes: on (b)(6) 2017: aleve tens device direct therapy: risk category v. Unconfirmed quality defectaleve tens gel pad: risk category v. Unconfirmed quality defect. Company causality comment: this spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6)-year-old male patient who received aleve tens device direct therapy unit / aleve tens gel pad for pain due to back injury (unapproved indication). The events are considered serious due to medical importance and intervention required and are unlisted in the reference safety information for aleve tens. The patient's concurrent conditions included back injury and allergy to iodine and sea food. Consumer had been using the device for about one month with good results and no other problem when he had the events. Patient visited a pharmacist who gave him hydro cream and the burns and vesicles were recovering. In this context, considering the close temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information has been requested.
 
Manufacturer Narrative
Most recent follow-up information incorporated above includes: on 11-apr-2017: indication for aleve tens gel pads replacement 4ct was added as "pain". Lot number for aleve tens direct therapy device 1ct "t050hl" was added. Outcome for the events "medical device site burn", "medical device site vesicles" and "medical device site discomfort" was changed from recovering to not recovered. Company causality comment: this spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit / aleve tens gel pad for pain due to back injury (unapproved indication). The events are considered serious due to medical importance and intervention required and are unlisted in the reference safety information for aleve tens. The patient's concurrent conditions included back injury and allergy to iodine and seafood. Consumer had been using the device for about one month with good results and no other problem when he had the events. Patient visited a pharmacist who gave him hydro cream and the burns and vesicles were recovering. In this context, considering the close temporal relationship and the lack of alternative explanation for events, causality of aleve tens cannot be excluded. Further information has been requested.
 
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit (batch no. T050hl) for pain. The occurrence of additional non-serious events is detailed below. Co-suspect products included aleve tens gel pad for pain. Other product or product use issues identified: device use issue "i used this everyday for 3-4 weeks", device use issue "i used this to help a back injury" and therapeutic response unexpected "this helped my back pain from an injury". Medical conditions: the patient saw a pharmacist who gave him an hydro cream. Concurrent conditions included iodine allergy, seafood allergy and back injury (third back injury). Concomitant products included cardiovascular system drugs (blood pressure medication (nos)). In (b)(6) 2016, the patient started aleve tens device direct therapy unit, unkmultiple treatment cycles. In (b)(6) 2016, the patient started aleve tens gel pad at an unspecified dose and frequency. On (b)(6) 2017, the patient experienced medical device site burn (seriousness criteria medically significant and intervention required), medical device site vesicles (seriousness criteria medically significant and intervention required) and medical device site discomfort ("this felt a stronger on my back"). Aleve tens device direct therapy unit was withdrawn. Aleve tens gel pad was withdrawn. At the time of the report, the medical device site burn, medical device site vesicles and medical device site discomfort had not resolved. The reporter considered medical device site burn, medical device site discomfort and medical device site vesicles to be related to aleve tens device direct therapy unit and aleve tens gel pad. 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, passed pcba and hla functional test. No deviations or non-conformances were noted during the manufacturing process and documentation. Missing remote label is not caused by plexus. Damaged main unit battery door cover is not caused by plexus. A product quality defect was unconfirmed, therefore the reported events are unlikely related to a product quality issue. 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. Quality safety evaluation of ptc. Unconfirmed quality defect. If no samples are available and no batch data of the medicinal product or medical device have been reported in the closed without further investigation. Most recent follow-up information incorporated above includes: on 6-jul-2017: quality-safety evaluation of ptc. Company causality comment: this spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit / aleve tens gel pad for pain. The events are considered serious due to medical importance and intervention required and are unlisted in the reference safety information for aleve tens. The patient's concurrent conditions included back injury and allergy to iodine and sea food. Consumer had been using the device for about one month with good results and no other problem when he had the events. Patient visited a pharmacist who gave him hydro cream and the burns and vesicles were recovering. In the context of the report, considering the close temporal relationship and the lack of alternative explanation for events, causality of aleve tens and aleve tens gel pad cannot be excluded. Ptc investigation did not find non-conformances or quality defects.
 
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit for pain. The occurrence of additional non-serious events is detailed below. Co-suspect products included aleve tens gel pad for pain. Other product or product use issues identified: device use issue "i used this everyday for 3-4 weeks", device use issue "i used this to help a back injury" and therapeutic response unexpected "this helped my back pain from an injury". Medical conditions: the patient saw a pharmacist who gave him an hydro cream. Concurrent conditions included iodine allergy, seafood allergy and back injury (third back injury). Concomitant products included cardiovascular system drugs (blood pressure medication (nos)). On an unknown date, the patient started aleve tens device direct therapy unit. In (b)(6) 2016, the patient started aleve tens gel pad at an unspecified dose and frequency. On (b)(6) 2017, the patient experienced medical device site burn (seriousness criteria medically significant and intervention required), medical device site vesicles (seriousness criteria medically significant and intervention required) and medical device site discomfort ("this felt a stronger on my back"). Aleve tens device direct therapy unit was withdrawn. Aleve tens gel pad was withdrawn. At the time of the report, the medical device site burn, medical device site vesicles and medical device site discomfort had not resolved. The reporter considered medical device site burn, medical device site discomfort and medical device site vesicles to be related to aleve tens device direct therapy unit and aleve tens gel pad. 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 of the aleve tens device regarding serial # (b)(4), the product investigation was not able to identify any defects or issues with the product. The returned product tested within the product specifications. In addition a device history record review was performed which indicated the product was manufactured to specifications and passed all qc tests; no non-conformances or deviations were associated with this product. Addition of quality-safety evaluation and ptc source document, update of ptc global number, addition of fda evaluation codes and update of lot number based on the technical investigation of the aleve tens gel pad, an in depth ptc investigation cannot be conducted by the quality unit as a batch 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 3-aug-2017: results of quality-safety evaluation added and lot number updated. This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("my skin looks burned where the unit was / caused severe burns on my back") and medical device site vesicles ("i have blisters where the unit was / caused blisters on my back") in a (b)(6) male patient who received aleve tens device direct therapy unit / aleve tens gel pad for pain. The events are considered serious due to medical importance and intervention required and are unlisted in the reference safety information for aleve tens. The patient's concurrent conditions included back injury and allergy to iodine and sea food. Consumer had been using the device for about one month with good results and no other problem when he had the events. Patient visited a pharmacist who gave him hydro cream and the burns and vesicles were recovering. In the context of the report, considering the close temporal relationship and the lack of alternative explanation for events, causality of aleve tens and aleve tens gel pad cannot be excluded. Ptc investigation did not find non-conformances or quality defects, the quality unit evaluation was unable to confirm the complaint based on the returned, tested aleve tens device.
 
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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 Key6373445
MDR Text Key68853258
Report Number1020060-2017-00004
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 08/15/2017
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
Device Operator
Device Lot NumberT050HL, R05Y64
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2017
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 Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1
Treatment
BLOOD PRESSURE MEDICATION (NOS) (CARDIOVASCULAR
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