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

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/13/2015

Event Type  Injury  

Event Description

Initial information regarding this unsolicited device case from united states was received from the consumer (patient's child) on (b)(4) 2015.This case involves an elder female patient of unknown age, who experienced application site burn (burn about the size of a dime in the area where the patch was adhered to her skin), few weeks 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 an unknown date in 2015, the patient started therapy with smart relief tens therapy occasionally over the last two or three weeks (indication, lot/batch number and expiry date: unknown).On (b)(6) 2015 in the night when the patient went to remove the adhesive pad, there were small welts and what appeared to be a contact burn about the size of a dime in the area where the patch was adhered to her skin (latency: few weeks).The patient was no longer comfortable using the product.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event pharmacovigilance comment: sanofi company comment dated (b)(4) 2015: this case concerns a patient who experienced application site burn whilst using smart relief tens therapy knee and shoulder.Although the role of smart relief tens therapy cannot be ruled out; however lack of information regarding condition of skin, duration of smart relief use, any serious intervention given or not, type of burn (second degree or third degree) precludes the comprehensive assessment of this case.

Event Description

Initial information regarding this unsolicited device case from united states was received from the consumer (patient's child) on (b)(6) 2015.This case involves an elder female patient of unknown age, who experienced application site burn (burn about the size of a dime in the area where the patch was adhered to her skin), few weeks 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 an unknown date in 2015, the patient started therapy with smart relief tens therapy occasionally over the last two or three weeks (indication, lot/batch number and expiry date: unknown).On (b)(6) 2015 in the night when the patient went to remove the adhesive pad there were small welts and what appeared to be a contact burn about the size of a dime in the area where the patch was adhered to her skin (latency: few weeks).The patient was no longer comfortable using the product.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event qa review: all retains have been examined for correct packaging, seal, missing components, working control unit, legibility of lot numbers /expiration date, correct label and foreign matter.No anomalies were found that could contribute to this complaint.Follow up was received on 14-jan-2016: qa review was added.Pharmacovigilance comment: sanofi company comment follow up dated 14-01-2016:the follow up information dose not change the prior medical assessment of the case.Sanofi company comment dated 17-12-2015: this case concerns a patient who experienced application site burn whilst using smart relief tens therapy knee and shoulder.Although the role of smart relief tens therapy cannot be ruled out; however lack of information regarding condition of skin, duration of smart relief use, type of burn (second degree or third degree), age and medical history of the patient, precludes the 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: 5322030
• MDR Text Key: 34197682
• Report Number: 1022556-2015-78221
• 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: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• 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