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

Lot Number 612005

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of burn infection ("i got a burn on my back / the burn got infected") in a (b)(6)-year-old female patient who received aleve tens device direct therapy unit (batch no.T05whv) for low back pain.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient started aleve tens device direct therapy unit.In (b)(6) 2016, the patient experienced medical device site scab ("it started as a hard scab").On (b)(6)2016, the patient experienced burn infection (seriousness criteria medically significant and clinically significant/intervention required) and medical device site swelling ("my back swelled").In (b)(6) 2016, the patient experienced wound secretion ("the burn infected is still oozing").The patient was treated with bactrim (sulfamethoxazole/trimethoprim) and antibiotics.Aleve tens device direct therapy unit was withdrawn.In 2016, the medical device site scab had resolved.In (b)(6) 2016, the medical device site swelling had resolved.At the time of the report, the burn infection and wound secretion had resolved.The reporter provided no causality assessment for burn infection, wound secretion and medical device site swelling with aleve tens device direct therapy unit.The reporter considered medical device site scab to be related to aleve tens device direct therapy unit.Quality-safety evaluation of ptc: the reported defect cannot be confirmed at this time.An investigation report has been requested of the cmo and additional time is needed identify the cause.A follow up has been created where the conclusive assessment will be finalized upon receipt.This procedure is in alignment with the current version of gsop 115.Product technical complaint occurred: aleve tens - electrical problems.(b)(4).Investigation reviewed.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 22-feb-2017: correction: the seriousness criterion of intervention required was added.Company causality comment this spontaneous case reported by a consumer described the occurrence of a burn infection ("i got a burn on my back / the burn got infected") in a (b)(6) year-old female patient who received aleve tens device direct therapy unit for low back pain.This event is serious due to medical importance and intervention required and unlisted in the reference safety information for aleve tens.No other consumer`s concurrent conditions and medical history were reported.Consumer reported that the event started as a hard scab and consumer thought it would go away, but it had gotten very infected.Consumer`s doctor referred her to a surgeon and she had the burn lanced.She took antibiotics for treatment and event recovered.In this context, considering the close temporal relationship and the lack of alternative explanation for event, causality of aleve tens cannot be excluded.

Manufacturer Narrative

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of burn infection ("i got a burn on my back / the burn got infected") in a (b)(6) year-old female patient who received aleve tens device direct therapy unit (batch no.612005) for low back pain.The occurrence of additional non-serious events is detailed below.In (b)(6) 2016, 7 days before starting aleve tens device direct therapy unit, the patient experienced medical device site scab ("it started as a hard scab").On an unknown date, the patient started aleve tens device direct therapy unit.On (b)(6) 2016, the patient experienced burn infection (seriousness criteria medically significant and intervention required) and medical device site swelling ("my back swelled").In (b)(6) 2016, the patient experienced wound secretion ("the burn infected is still oozing").The patient was treated with bactrim (sulfamethoxazole/trimethoprim) and antibiotics.Aleve tens device direct therapy unit was withdrawn.In 2016, the medical device site scab had resolved.In (b)(6) 2016, the medical device site swelling had resolved.At the time of the report, the burn infection and wound secretion had resolved.The reporter provided no causality assessment for burn infection, medical device site swelling and wound secretion with aleve tens device direct therapy unit.The reporter considered medical device site scab to be related to aleve tens device direct therapy unit.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.8 kg/sqm.Quality-safety evaluation of ptc: based on the technical investigation on the tens direct therapy, 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.Based on the technical investigation on the gel pads, no samples were returned therefore, the product analysis could not be performed and unable to confirm the issue of the reported condition.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 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.Some of the contributing factors is not properly storing the gel pads, customer skin types, oils, and ph levels can impact the usage of the pads 2-5 applications.Due to that fact that no sample was provided, 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 17-oct-2017: results of quality-safety evaluation of ptc were updated.Product lot number was updated.This spontaneous case reported by a consumer described the occurrence of a burn infection ("i got a burn on my back / the burn got infected") in a (b)(6) year-old female patient who received aleve tens device direct therapy unit for low back pain.This event is serious due to medical importance and intervention required and unlisted in the reference safety information for aleve tens.No other consumer`s concurrent conditions and medical history were reported.Consumer reported that the event started as a hard scab and consumer thought it would go away, but it had gotten very infected.Consumer`s doctor referred her to a surgeon and she had the burn lanced.She took antibiotics for treatment and event recovered.In this context, considering the close temporal relationship and the lack of alternative explanation for event, causality of aleve tens cannot be excluded.

• 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: 6373336
• MDR Text Key: 68964773
• Report Number: 1020060-2017-00001
• 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: 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

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 612005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 64