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

Lot Number 15G115

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Tissue Damage (2104); No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Event Description

Initial information regarding this unsolicited device case from the united states was received from a patient on (b)(6) 2015.This case involves a male patient of unknown age who had back blisters, scabs and had application site burn (looked/felt somewhat like a sunburn) unspecified time frame after starting smart relief tens therapy (smart relief tens therapy back).The patient had medical history of back surgery in 2010 and has titanium rods in his back.No relevant past medications or concomitant medications were reported.On an unspecified date the patient started using smart relief tens therapy for back disorder (lot/batch number: 15g115 and expiration date: 30-sep-2017).Unit number was 1411031709221 and electrode pad number was-b-15-03-20 with expiration date 31-dec-2017.The patient reported that he had been using the product for a couple weeks and had a severe reaction.On an unspecified date (latency: unknown) he had back blisters, scabs and looked/felt somewhat like a sunburn.According to the patient, when he was sweating, the pad seemed to be melting completely.The patient mentioned that he has titanium rods in his back (device misuse) and he was informed that use of smart relief tens therapy was not recommend to customers with any metal implants, rods or cardiac pacemakers.Action taken: unknown.Information on corrective treatment was not provided.Outcome: unknown for all the events.This case was assessed as serious due to important medical events.Pharmacovigilance comment: sanofi company comment dated 08-dec-2015: this case concerns a male patient who experienced application site blisters, burns and scabs after application of company device smart relief tens therapy for back disorder.Although, the causal role of the drug cannot be denied; however, of note that patient used the device whilst having metal implants, which provides a plausible explanation.Furthermore, information regarding event details, the condition of the skin at the contact area prior to application of the device, any skin affliction, and allergy history would aid in a comprehensive case assessment.

Event Description

Initial information regarding this unsolicited device case from the united states was received from a patient on (b)(6) 2015.This case involves a male patient of unknown age who had back blisters, scabs and had application site burn (looked/felt somewhat like a sunburn) unspecified time frame after starting smart relief tens therapy (smart relief tens therapy back).The patient had medical history of back surgery in 2010 and has titanium rods in his back.No relevant past medications or concomitant medications were reported.On an unspecified date the patient started using smart relief tens therapy for back disorder (lot/batch number: 15g115 and expiration date: 30-sep-2017).Unit number was (b)(4)and electrode pad number was-b-15-03-20 with expiration date 31-dec-2017.The patient reported that he had been using the product for a couple weeks and had a severe reaction.On an unspecified date (latency: unknown) he had back blisters, scabs and looked/felt somewhat like a sunburn.According to the patient, when he was sweating, the pad seemed to be melting completely.The patient mentioned that he has titanium rods in his back (device misuse) and he was informed that use of smart relief tens therapy was not recommend to customers with any metal implants, rods or cardiac pacemakers.Action taken: unknown.Information on corrective treatment was not provided.Outcome: unknown for all the events.This case was assessed as serious due to important medical events.Qa review findings: 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 an adverse reaction from using the tens device; they experienced a burn that resulted in blisters and scabs.Additionally, the consumer stated that the pad appeared to be "melting".The device should be returned to investigate the state of the pad and whether or not it is operating within specification.No further investigation is possible at this time.Additional information was received on 02-dec-2015, qa review findings were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated (b)(4) 2015: this case concerns a male patient who experienced application site (back) blisters, burns and scabs after application of company device smart relief tens therapy for back disorder.Although, the causal role of the drug cannot be denied; however, of note, patient used the device whilst having metal implants (titanium rods in his back), which provides a plausible explanation for the event, since it is contraindicated in the presence of metallic implants.Furthermore, information regarding event details, the condition of the skin at the contact area prior to application of the device, any skin affliction, and allergy history would aid in a comprehensive case assessment.

Event Description

Based on additional information received on 23-mar- 2017, case was medically confirmed since follow up was received from hcp.Initial information regarding this unsolicited device case from the united states was received from a patient on 02-dec-2015.This case involves a (b)(6) male patient who had back blisters/pustule filled bumps after 6 weeks, scabs and had application site burn (looked/felt somewhat like a sunburn) unspecified time frame after starting smart relief tens therapy (smart relief tens therapy back).The patient had medical history of back surgery in 2010 and has titanium rods in his back due to t12 compression/burst fracture.Concomitant medications: naproxen sodium (aleve) for pain and tizanidine hydrochloride (zanaflex) for muscle spasm.Patient had no allergic history.On (b)(6) 2015, the patient started using smart relief tens therapy for chronic lower back pain 3-5 times daily (30 minutes session)(lot/batch number: 15g115 and expiration date: 30-sep-2017).Unit number was 1411031709221 and electrode pad number was-b-15-03-20 with expiration date 31-dec-2017.The patient reported that he had been using the product for a couple weeks and had a severe reaction.On an unspecified date in (b)(6) 2015 (latency: 6 weeks) he had back blisters.Since an unknown date and latency, patient had scabs and after unknown duration, in 2015 application site burn was reported and it looked/felt somewhat like sunburn.According to the patient, when he was sweating, the pad seemed to be melting completely.Since (b)(6) 2015, patient's lower back became covered in severe rash, itchy, irritating, pustule filled bumps covered 1/3 of patient's back.The patient mentioned that he has titanium rods in his back (device misuse) and he was informed that use of smart relief tens therapy was not recommend to customers with any metal implants, rods or cardiac pacemakers.Patient used other tens unit with no side effects.Action taken: unknown, however, therapy was stopped on (b)(6) 2015.Corrective treatment: none for application site blister, not reported for application site scab and application site burn.Outcome: recovered for back blisters/pustule filled bumps after 2-3 weeks of therapy stop and unknown for rest of events.This case was assessed as serious due to important medical events.Qa review findings: 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 an adverse reaction from using the tens device; they experienced a burn that resulted in blisters and scabs.Additionally, the consumer stated that the pad appeared to be "melting".The device should be returned to investigate the state of the pad and whether or not it is operating within specification.No further investigation is possible at this time.Additional information was received on 02-dec-2015, qa review findings were added.Text amended accordingly.Additional information received on 23-mar-2017, case was medically confirmed since follow up was received from hcp: information on patient added (weight and height, age), concomitant medications and medical history added, therapy details with suspect device updated (start date, stop date, indication).Event verbatim and outcome for application site blister updated.Symptoms of application site itching, application site rash and application site irritation added.Clinical course updated.Pharmacovigilance comment: sanofi company comment dated 29 mar 2017: this case concerns a male patient who experienced application site (back) blisters, burns and scabs,irritation, rash,itching after application of company device smart relief tens therapy for back disorder.Although, the causal role of the drug cannot be denied; however, of note, patient used the device whilst having metal implants (titanium rods in his back), which provides a plausible explanation for the event, since it is contraindicated in the presence of metallic implants.Furthermore, information regarding event details, the condition of the skin at the contact area prior to application of the device, any skin affliction, and allergy history would aid in a comprehensive case assessment.

• 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: heather schiappacasse ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 5289173
• MDR Text Key: 33272727
• Report Number: 1022556-2015-78220
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Lot Number: 15G115
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2015; 04/04/2017
• 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: 53 YR
• Patient Weight: 64