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U.S. Department of Health and Human Services

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

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BAYER HEALTHCARE LLC, CONSUMER CARE ALEVE DIRECT THERAPY TENS STIMULATOR, NERVE, TRANSCUTANEOUS, ELECTRICAL NERVE STIMULATOR (TENS) Back to Search Results
Lot Number 608549
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("device getting hot on one side and smoking, and charred the black pad and the gel pad") in a female patient who received aleve tens device direct therapy unit (batch no. 608549) for back pain. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced device material issue. The reporter commented: i just contacted customer service do to my device getting hot and smoking, luckily i was not burnt. The device just got hot on one side and charred the black pad and the gel pad. I have had this for 3 months without any problems quality-safety evaluation of ptc: based on the technical investigation, a review of the device history for this serial number was conducted and no defects were identified during the manufacture of the device. The device was returned to bayer and passed testing. Regarding the tens gelpads- the customer returned 2 gel pads stuck together in a small zip lock bag. The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer. The investigation team has reviewed the equipment, material and process and the probable root cause of the reported condition as stated by the customer. Visual inspection through the microscope confirmed the electrodes were applied to patients as derma was present. One gel pad had a dark brown area with a small area missing gel with only the scrim present. Within that area there appeared to be some evidence of hardened gel. There was very little "tack" from the gel when touched with a nitrile glove, this is consistent with gel pads that have been used. The reported condition was not confirmed. Through the product analysis of the reported condition as stated by the customer, it has been determined that the probable root cause is not related to the gel pad. No defects were identified 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. 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 19-dec-2017: quality-safety evaluation of ptc was received. This spontaneous report refers to a female patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) for severe back pain on unspecified dates. Within 3 months of use without any problem, device got hot on one side and smoking, and charred the black pad and the gel pad. Patient was not burnt. The event was considered non-serious and is listed according aleve tens device direct therapy unit. At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury. However there was a potential for harm to the patient if the device issue happened while it was attached to the skin. Further information was requested. This case was regarded as incident. The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.
 
Event Description
This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("device getting hot on one side and smoking, and charred the black pad and the gel pad") in a female patient who received aleve tens device direct therapy unit for back pain. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced device material issue. The reporter commented: i just contacted customer service do to my device getting hot and smoking, luckily i was not burnt. The device just got hot on one side and charred the black pad and the gel pad. I have had this for 3 months without any problems most recent follow-up information incorporated above includes: on 29-nov-2017: upon internal quality review, the reported events were revised to device getting hot on one side and smoking, and charred the black pad and the gel pad. Moreover, case category was updated to incident as there was a potential for harm to the patient if device was attached to the skin. This spontaneous report refers to a female patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) for severe back pain on unspecified dates. Within 3 months of use without any problem, device got hot on one side and smoking, and charred the black pad and the gel pad. Patient was not burnt. The event was considered non-serious and is listed according aleve tens device direct therapy unit. At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury. However there was a potential for harm to the patient if the device issue happened while it was attached to the skin. Further information was requested. This case was regarded as incident.
 
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Brand NameALEVE DIRECT THERAPY TENS
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, ELECTRICAL NERVE STIMULATOR (TENS)
Manufacturer (Section D)
BAYER HEALTHCARE LLC, CONSUMER CARE
36 columbia road
morristown NJ 07960
Manufacturer (Section G)
BAYER HEALTHCARE LLC, CONSUMER CARE
36 columbia road
morristown NJ 07960
Manufacturer Contact
k. shaw lamberson
100 bayer blvd.
p.o. box 915
whippany 07981-0915
MDR Report Key7083059
MDR Text Key249473601
Report Number2248903-2017-00002
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
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number608549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/18/2018
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

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