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

Lot Number R0M5JU

Device Problems Output above Specifications (1432); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report was initially received on 28-feb-2018.At the time, the case was only a ptc without event and not classified as incident (no criterion for case creation).However following ptc investigation (finalized on 31-jul-2018), the device electrical finding has been identified and classified as incident, therefore the case has been created now.This spontaneous case was reported by a consumer and describes the occurrence of device electrical finding ("output voltage of the product was higher than the allowable specification limit") and device malfunction ("device worked for 2 days (device flash green, but there's no output from the device)") in a male patient who received aleve tens device direct therapy unit (batch no.(b)(4)).On an unknown date, the patient started aleve tens device direct therapy unit.On an unknown date, the patient experienced device electrical finding and device malfunction.Quality-safety evaluation of ptc: based on the technical investigation, the initially reported complaint was for the product failing to function after 2 days of use.The complaint sample was returned for analysis and testing.The returned product failed the initial testing where additional testing was performed by the manufacturer.The initial and additional evaluation of the test results showed that the output voltage of the product was higher than the allowable specification limit.The device history record was reviewed for tens serial number (b)(4) and remote serial number (b)(4); the unit passed printed circuit board assembly level testing & high level assembly functional test during manufacture where no deviations or non-conformances were noted during the manufacturing process.The hazard analysis document was reviewed and failure modes associated with output resulting in current exceeding maximum value is captured within the existing risk document and determined to be broadly acceptable.Though a potential exists for consumer injury or harm, there were no adverse events reported with the use of this device serial number.Reason no capa necessary, the unit passed high level assembly functional test (test step sf1) before being shipped.This defect was not induced in plexus as the united tested pass the sf1 test.No adverse trends for this failure analysis trend was observed.This is the first confirmed complaint of this nature and is considered an isolated incident since defects of this nature have not been previously confirmed.This defect will continue to be monitored by bayer quality assurance and further actions will be taken if required.A product quality defect was confirmed.No adverse events were reported with the use of this device serial number.Most recent follow-up information incorporated above includes: on 31-jul-2018: quality-safety evaluation of ptc.Events are listed in the reference safety information for aleve tens device direct therapy unit.Given this device´s electrical nature, both events are considered related to product.Following ptc results, it was reported that output voltage of the product was higher than the allowable specification limit, which could lead to patient harm, and therefore this case was regarded as an 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: 7752239
• MDR Text Key: 116402626
• Report Number: 2248903-2018-00003
• 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
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: R0M5JU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Date Manufacturer Received: 02/28/2018
• 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: N
• Patient Sequence Number: 1