MAUDE Adverse Event Report: CHATTEM SMART RELIEF TENS THERAPY KNEE AND SHOULDER; TRANSCUTANEOUS NERVE STIMULATOR

Lot Number 15F503

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Initial information regarding this unsolicited serious device case from united states was received from the patient's wife on (b)(4) 2015.This case involves a (b)(6) years old male patient, who experienced second degree burns, unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).Past drugs, medical history and concomitant medications were not reported.On unknown, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/ batch number: 15f503 and expiry date: 30-oct-2017; electrode pad lot: b-15-03-19 and expiry date: oct-2017 and serial no: (b)(4)) for pain in shoulder.The reporter mentioned that she was reading the instructions and was following what was displayed and has placed it across his shoulder.She stated that it was lightening up and when she presses the plus button that it will pulsates for 1 sec and doesn't do anything anymore.The reporter said that she replaced the battery but the device was still doing the same thing.The reporter mentioned that when she took the device off his shoulders this morning (reporting day) that the green light was still blinking but the device was not in use.She reported that patient had the burn last week but she didn't mention because she was not aware at the time.He had to go to the hospital for pain in shoulder.The patient experienced second degree burns (onset time and latency: unknown) and they treated him by applying cream on it.Reportedly, he did not go to the hospital for the burn, but for the pain in his shoulder.She reported there was no indication/warning about burns (labeling/instructions), what would cause it.Action taken: unknown.Corrective treatment: unspecified cream.Outcome: unknown.Seriousness criteria: important medical event.Pharmacovigilance comment: sanofi company comment for follow up dated (b)(4) 2015: this case concerns a (b)(6)-years-old-male patient who developed second degree burns while using samart relief tens therapy knee and shoulder.Although the role of device cannot can-not be denied for the events; however lack of information regarding condition of the skin at the contact area prior to applying the device, history of allergies, concurrent condition precludes a comprehensive assessment of this case.

Event Description

Initial information regarding this unsolicited serious device case from united states was received from the patient's wife on (b)(6) 2015.This case involves a (b)(6) male patient, who experienced second degree burns, unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).Past drugs, medical history and concomitant medications were not reported.On unknown, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/ batch number: 15f503 and expiry date: 30-oct-2017; electrode pad lot: b-15-03-19 and expiry date: oct-2017 and serial no: (b)(4)) for pain in shoulder.The reporter mentioned that she was reading the instructions and was following what was displayed and has placed it across his shoulder.She stated that it was lightening up and when she presses the plus button that it will pulsates for 1 sec and doesn't do anything anymore.The reporter said that she replaced the battery but the device was still doing the same thing.The reporter mentioned that when she took the device off his shoulders this morning (reporting day) that the green light was still blinking but the device was not in use.She reported that patient had the burn last week but she didn't mention because she was not aware at the time.He had to go to the hospital for pain in shoulder.The patient experienced second degree burns (onset time and latency: unknown) and they treated him by applying cream on it.Reportedly, he did not go to the hospital for the burn, but for the pain in his shoulder.She reported there was no indication/warning about burns (labeling/instructions), what would cause it.Action taken: unknown.Corrective treatment: unspecified cream.Outcome: unknown.Seriousness criteria: important medical event.Qa review findings: received one tens unit serial number (b)(4) and one (b)(6) battery for evaluation.Upon visual inspection, the tens unit was in good condition.The unit was fully functional with both the received and a new battery; complete and consistent stimulation was present.There was no unusual or erratic operation noted.Because of the severity of the second degree burn claim, the control unit was not only heavily inspected, but also tested in conjunction with a new electrode pad.Elements on the pcb, such as resistors, were measured to ensure that the values were as intended.No unusual readings were found.When the unit was tested with a new electrode pad, strong and consistent stimulation was present.Again, there was no erratic or unusual operation.Therefore, through this investigation, it can be confirmed that the adverse event that occurred was not due to a device malfunction or defect; the device operated within specification.Therefore, there were no faults found with this device.Final conclusion: no faults found with this device root cause: no faults found with this device additional information was received on 12-oct-2015, qa review findings added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 12-10-2015: based upon the device event temporal relationship the role of smart relief tens therapy knee and shoulder cannot be determined for the event of second degree burns, however investigations performed on device has confirmed that there are no faults in the device used.Sanofi company comment for follow up dated 14-10-2015: this case concerns a (b)(6) male patient who developed second degree burns while using smart relief tens therapy knee and shoulder.Although the role of device cannot be denied for the events; however lack of information regarding condition of the skin at the contact area prior to applying the device, history of allergies, concurrent condition precludes a comprehensive assessment of this case.

• Brand Name: SMART RELIEF TENS THERAPY KNEE AND SHOULDER
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM; 1715 west 38th street; chattanooga TN 37409
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5156483
• MDR Text Key: 28553028
• Report Number: 1022556-2015-78217
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2017
• Device Lot Number: 15F503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 95 YR