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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction, Injection Site (2442)

Event Type  Injury  

Event Description

Initial information regarding this unsolicited device case from united states was received from a nonhealthcare professional reporter (patient's friend) on (b)(6) 2015.This case involves a female patient of unknown age who developed blisters on her lower back an unspecified time frame after starting use of smart relief tens therapy (icy hot smart relief tens back pain therapy).No relevant past medications, medical history, concurrent conditions or concomitant medications were reported.The patient recently purchased the smart relief tens therapy and on an unspecified date she started using smart relief tens therapy for back disorder (lot/batch number and expiration date: not provided).The reporter mentioned that since using the product (since unknown date, latency: unknown) the patient had developed blisters on her lower back where she was using the device.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.This case was assessed as serious due to important medical event of "blisters on her lower back".Pharmacovigilance comment: sanofi company comment dated (b)(6) 2015: this case concerns a female patient of unknown age who developed application site blister while on therapy with smart relief tens therapy back.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 leads and duration of device usage will preclude further assessment of this case.

Event Description

Initial information regarding this unsolicited device case from united states was received from a nonhealthcare professional reporter (patient's friend) on (b)(6) 2015.This case involves a female patient of unknown age who developed blisters on her lower back an unspecified time frame after starting use of smart relief tens therapy (icy hot smart relief tens back pain therapy).No relevant past medications, medical history, concurrent conditions or concomitant medications were reported.The patient recently purchased the smart relief tens therapy and on an unspecified date she started using smart relief tens therapy for back disorder (lot/batch number and expiration date: not provided).The reporter mentioned that since using the product (since unknown date, latency: unknown) the patient had developed blisters on her lower back where she was using the device.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Qa review was performed and investigation findings were reported as "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 the consumer stated that they received blisters from using the device; they do not specify the severity of the burns or blistering.A device operating within proper specification should not cause burns or blistering.Further correspondence or device return is necessary to continue investigation".This case was assessed as serious due to important medical event of "blisters on her lower back".Additional information was received on 19-jan-2016: qa review findings were added and narrative was updated accordingly.Pharmacovigilance comment: sanofi company comment dated 22-10-2015: this case concerns a female patient of unknown age who developed application site blister while on therapy with smart relief tens therapy back.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 leads and duration of device usage will preclude further assessment of this case.

• Brand Name: ICY HOT SMART RELIEF TENS BACK PAIN THERAPY
• 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: 5180074
• MDR Text Key: 29325176
• Report Number: 1022556-2015-78218
• 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: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• 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: 01/19/2016
• 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