MAUDE Adverse Event Report: CHATTEM SMART RELIEF TENS THERAPY BACK; TRANSCUTANEOUS NERVE STIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Bruise/Contusion (1754)

Event Date 03/20/2016

Event Type  Injury  

Event Description

Initial information regarding unsolicited device case was received from a patient on 23-mar-2016.This case involves a (b)(6) years old female patient who was getting blisters, unknown duration after starting smart relief tens therapy (smart relief tens therapy back).Concomitant medication and relevant medical history was not provided.On an unknown date (from over a year), the patient started smart relief tens therapy (lot/batch number, expiration date and other dosing details were unknown).Reportedly, from the past couple of months, patient was getting blisters whenever she took the pad off, and this had never happened before.Patient mentioned that the device gave her very itchy blisters.Action taken: unknown.Information on corrective treatment was not provided.Outcome was unknown.Seriousness criteria: ime.Pharmacovigilance comment: sanofi company comment dated 23-mar-2016: this case concerns a (b)(6) years old female patient who is experiencing blisters.This case cannot be assessed due to lack of information.Moreover, information regarding relevant medical history, concurrent conditions, condition of the skin at the contact area prior to applying the device, history of allergies, concomitant medications and event details will preclude further assessment of this case.

Event Description

Initial information regarding unsolicited device case was received from a patient on (b)(6) 2016.This case involves a (b)(6) female patient who was getting blisters, unknown duration after starting smart relief tens therapy (smart relief tens therapy back).Concomitant medication and relevant medical history was not provided.On an unknown date (from over a year), the patient started smart relief tens therapy (lot/batch number, expiration date and other dosing details were unknown).Reportedly, from the past couple of months, patient was getting blisters whenever she took the pad off, and this had never happened before.Patient mentioned that the device gave her very itchy blisters.Action taken: unknown.Information on corrective treatment was not provided.Outcome was unknown.Seriousness criteria: ime.Qa review: the device history files were reviewed at the time of the complaint for any anomaly, deviation or investigation, documented or otherwise that might result in any type of complaint against the lot.No evidence of root cause was found in the device history files.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.Additional information was received on 28-mar-2016: qa review was added.Pharmacovigilance comment: sanofi company comment dated 23-03-2016: this case concerns a (b)(6)-female patient who developed blisters while on therapy with smart relief tens therapy.This case cannot be assessed due to lack of information.Moreover, information regarding relevant medical history, concurrent conditions, condition of the skin at the contact area prior to applying the device, history of allergies, concomitant medications and event details will preclude further assessment of this case.

• Brand Name: SMART RELIEF TENS THERAPY BACK
• 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: 5540589
• MDR Text Key: 41611896
• Report Number: 1022556-2016-00004
• 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: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR