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

Lot Number 17E111

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

Patient Problems Local Reaction (2035); Skin Discoloration (2074)

Event Date 09/10/2017

Event Type  Injury  

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on (b)(6) 2017.This case concerns a female patient of unspecified age who had blistered, skin coming off, burns and skin was raw after using smart relief tens therapy (smart relief tens therapy back).She had implanted teeth (metallic implant).No past drugs and concomitant medication were reported.On an unknown date, the patient commenced therapy with smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date: 31-jul-2019; indication not reported).The control unit serial number: (b)(4).The patient had burns after using the smart relief tens.It was reported that her skin was raw and blistered with skin coming off her hip (onset date and latency not reported for all events) after using the smart relief tens therapy.She went to the doctor and he gave her some medicinal ointment and bandaged the area (corrective treatment for application site peeling and skin texture abnormal).Action taken: permanently discontinued.Corrective treatment: medical ointment for burns and blisters.Outcome: unknown.Seriousness criteria: important medical history (blistered, burn and skin coming off).

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 13- sep-2017.This case concerns a female patient of unspecified age who had blistered, skin coming off, burns and skin was raw after using smart relief tens therapy (smart relief tens therapy back).She had implanted teeth (metallic implant).No past drugs and concomitant medication were reported.On an unknown date, the patient commenced therapy with smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date: 31-jul-2019; indication not reported).The control unit serial number: (b)(4).The patient had burns after using the smart relief tens.It was reported that her skin was raw and blistered with skin coming off her hip (onset date and latency not reported for all events) after using the smart relief tens therapy.She went to the doctor and he gave her some medicinal ointment and bandaged the area (corrective treatment for application site peeling and skin texture abnormal).Action taken: permanently discontinued corrective treatment: medical ointment for burns and blisters.Outcome: unknown.Seriousness criteria: important medical history (blistered, burn and skin coming off).Qa review findings: the consumer reported receiving burns and blisters on hip from device use.Additionally, consumer stated that they have teeth implants, but no other metallic implants throughout the body.The warnings section on the back of the device box states, "do not use this device under any circumstance if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device." a thorough investigation (richard willis, capa protocol and review of ihsr [2014]) has been done to investigate the likelihood of the ihsr producing burns in some users.This investigation found that it is highly unlikely for the smart relief to produce tissue trauma.The maximum current and power density calculated for the smartrelief is a tiny fraction of the limits in the fda guidance.The complete investigation is located in the device files.The coa for electrode lot number b-17-01-08 confirmed that all inspection items were passed.Device return is not expected at this time; therefore, additional investigation is not possible.Additional information was received on 19-sep-2017 from quality department, qa review findings were added.Text amended accordingly.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 13- sep-2017.This case concerns a (b)(6) years old female patient who had 2nd degree burn on buttocks, blistered, skin coming off and skin was raw, after using smart relief tens therapy (smart relief tens therapy back).The patient had implanted teeth (metallic implant).Medical history also included rheumatoid arthritis, joint pain, hypertension (401.9) and smoking less than 100 in lifetime.The patient had no known medication allergies.Concomitant medications included hydrochlorothiazide and nebivolol hydrochloride (bystolic) for blood pressure, potassium, hydrocodone bitartrate/paracetamol (lortab), sulfamethoxazole/ trimethoprim (septra ds), clarithromycin, pantoprazole sodium (protonix) and benzonatate (tessalon).On (b)(6) 2017, the patient commenced therapy with smart relief tens therapy thrice daily (lot/batch number: 17e111 and expiry date: 31-jul-2019) for chronic hip pain.The control unit serial number was (b)(4).On (b)(6) 2017 (latency: 2 days) patient experienced 2nd degree burn on buttocks.It was reported that her skin was raw and blistered with skin coming off her hip (onset date: (b)(6) -2017 and latency: unknown for all events) after using the smart relief tens therapy.She went to the doctor and he gave her some medicinal ointment and bandaged the area.The dressings or debridement of partial thickness burns, initial or subsequent, small (less than 5% total body surface area).Action taken: permanently discontinued on (b)(6) 2017.Corrective treatment: silver sulfadiazine for burns second degree; medical ointment and bandaged the area for application site peeling and skin texture abnormal; medical ointment for application site blister outcome: not recovered for burns second degree; unknown for other events.Qa review was performed and investigation findings were reported as (for lot/batch: 17e111): received one tens unit serial number (b)(4), one panasonic battery, and one electrode lot: b-17-01-08 for investigation.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 output.No erratic output was noted and the control unit functioned as intended.The pad was in bad condition but stored on a clear, protective sheet; it was dirty and had peeling/missing gel.The left impedance readings of the pad were 560o and 610o, and the right impedance readings were 640o and 570o; impedance was uniform across several locations of the pad and hot spots were not noted.However, the bad condition of the pad indicates limited functionality.Per device precautions, "the adhesive characteristics of electrode pads may affect the safety and effectiveness of electrical stimulation.Clean and/or replace the electrode pads as directed." additionally, consumer applied device to buttocks, which is not an approved site of application for the back & hip device.Lastly, consumer has implanted metal in teeth; use of product with any implanted metal is not recommended.Therefore, the improper use by consumer and worn pad may have contributed to adverse event.Per evaluation, adverse event cannot be attributed to device malfunction.Final conclusion: improper device use / worn pad.Seriousness criteria: important medical history for all events except skin texture abnormal (which was nonserious).Additional information was received on 19-sep-2017 from quality department: qa review findings were added.Text amended accordingly.Additional information was received on 04-oct-2017 from the patient: age, weight and height of patient added, medical history and concomitant medications added.Event of application site burn updated to burns second degree, therapy details with suspect updated (start date, stop date, indication).Onset of previously reported events of application site peeling, skin texture abnormal and application site blister was also updated.Clinical course was updated.Additional information was received on 10-oct-2017 from quality department: qa review was added.Follow-up information was received on 25-oct-2017 from the patient: no new information was received.Follow up was received on 07-nov-2017 and 08-nov-2017 both processed together with csd of 07-nov-2017, no new information was received.Additional information was received on 10-nov-2017 from the quality department: qa review added for the received sample.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 10-11-2017: the follow up information does not change the previous assessment of case.Sanofi company comment for follow-up dated 04-10-2017: this case concerns an elderly female patient who experienced second degree burn, application site peeling and application site blister while on therapy with smart relief tens therapy.The casual role assessed as possible based on temporal relationship, however, more information regarding concurrent illness, past drugs and lifestyle history can aid in comprehensive case assessment.Additionally, elderly age of the patient acts as confounder for the same.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 13- sep-2017.This case concerns a (b)(6) years old female patient who had 2nd degree burn on buttocks, blistered, skin coming off and skin was raw after using smart relief tens therapy (smart relief tens therapy back).She had implanted teeth (metallic implant).Medical history also included rheumatoid arthritis, joint pain, hypertension, smoking less than 100 in lifetime.Concomitant medications: hydrochlorothiazide and nebivolol hydrochloride (bystolic) for blood pressure, potassium, hydrocodone bitartrate/paracetamol (lortab), sulfamethoxazole/trimethoprim (septra ds), clarithromycin, pantoprazole sodium (protonix) and benzonatate (tessalon).On (b)(6) 2017, the patient commenced therapy with smart relief tens therapy thrice daily (lot/batch number: 17e111 and expiry date: 31-jul-2019) for chronic hip pain.The control unit serial number: (b)(4).On (b)(6) 2017 (latency: 2 days) patient experienced 2nd degree burn on buttocks.It was reported that her skin was raw and blistered with skin coming off her hip (onset date: (b)(6) 2017 and latency not reported for all events) after using the smart relief tens therapy.She went to the doctor and he gave her some medicinal ointment and bandaged the area.Action taken: permanently discontinued on (b)(6) 2017.Corrective treatment: silver sulfadiazine for burns second degree, medical ointment and bandaged the area for application site peeling and skin texture abnormal, medical ointment for application site blister outcome: not recovered for burns second degree and unknown for other events.Seriousness criteria: important medical history for all except skin texture abnormal (which was non-serious).Qa review findings: the consumer reported receiving burns and blisters on hip from device use.Additionally, consumer stated that they have teeth implants, but no other metallic implants throughout the body.The warnings section on the back of the device box states, "do not use this device under any circumstance if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device." a thorough investigation (richard willis, capa protocol and review of ihsr [2014]) has been done to investigate the likelihood of the ihsr producing burns in some users.This investigation found that it is highly unlikely for the smart relief to produce tissue trauma.The maximum current and power density calculated for the smartrelief is a tiny fraction of the limits in the fda guidance.The complete investigation is located in the device files.The coa for electrode lot number b-17-01-08 confirmed that all inspection items were passed.Device return is not expected at this time; therefore, additional investigation is not possible.Additional information was received on 19-sep-2017 from quality department, qa review findings were added.Text amended accordingly.Additional information was received on 04-oct-2017 from the patient: age, weight and height of patient added, medical history and concomitant medications added.Event of application site burn updated to burns second degree, therapy details with suspect updated (start date, stop date, indication).Onset of previously reported events of application site peeling, skin texture abnormal and application site blister was also updated.Clinical course was updated.Pharmacovigilance comment: sanofi company comment for follow-up dated 04-10-2017: this case concerns an elderly female patient who experienced second degree burn, application site peeling and application site blister while on therapy with smart relief tens therapy.The casual role assessed as possible based on temporal relationship, however, more information regarding concurrent illness, past drugs and lifestyle history can aid in comprehensive case assessment.Additionally, elderly age of the patient acts as confounder for the same.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on (b)(6) 2017.This case concerns a (b)(6) female patient who had 2nd degree burn on buttocks, blistered, skin coming off and skin was raw after using smart relief tens therapy (smart relief tens therapy back).She had implanted teeth (metallic implant).Medical history also included rheumatoid arthritis, joint pain, hypertension, smoking less than 100 in lifetime.Concomitant medications: hydrochlorothiazide and nebivolol hydrochloride (bystolic) for blood pressure, potassium, hydrocodone bitartrate/paracetamol (lortab), sulfamethoxazole/trimethoprim (septra ds), clarithromycin, pantoprazole sodium (protonix) and benzonatate (tessalon).On (b)(6) 2017, the patient commenced therapy with smart relief tens therapy thrice daily (lot/batch number: 17e111 and expiry date: 31-jul-2019) for chronic hip pain.The control unit serial number: (b)(4).On (b)(6) 2017 (latency: 2 days) patient experienced 2nd degree burn on buttocks.It was reported that her skin was raw and blistered with skin coming off her hip (onset date: (b)(6) 2017 and latency not reported for all events) after using the smart relief tens therapy.She went to the doctor and he gave her some medicinal ointment and bandaged the area.Action taken: permanently discontinued on 13-sep-2017.Corrective treatment: silver sulfadiazine for burns second degree, medical ointment and bandaged the area for application site peeling and skin texture abnormal, medical ointment for application site blister outcome: not recovered for burns second degree and unknown for other events.Seriousness criteria: important medical history for all except skin texture abnormal (which was non-serious).Qa review findings: the consumer reported receiving burns and blisters on hip from device use.Additionally, consumer stated that they have teeth implants, but no other metallic implants throughout the body.The warnings section on the back of the device box states, "do not use this device under any circumstance if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device." a thorough investigation (richard willis, capa protocol and review of ihsr [2014]) has been done to investigate the likelihood of the ihsr producing burns in some users.This investigation found that it is highly unlikely for the smart relief to produce tissue trauma.The maximum current and power density calculated for the smartrelief is a tiny fraction of the limits in the fda guidance.The complete investigation is located in the device files.The coa for electrode lot number b-17-01-08 confirmed that all inspection items were passed.Device return is not expected at this time; therefore, additional investigation is not possible.The device history files are reviewed 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 are 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 19-sep-2017 from quality department, qa review findings were added.Text amended accordingly.Additional information was received on 04-oct-2017 from the patient: age, weight and height of patient added, medical history and concomitant medications added.Event of application site burn updated to burns second degree, therapy details with suspect updated (start date, stop date, indication).Onset of previously reported events of application site peeling, skin texture abnormal and application site blister was also updated.Clinical course was updated.Additional information was received on 10-oct-2017 from quality department: qa review was added.Pharmacovigilance comment: sanofi company comment for follow-up dated 04-10-2017: this case concerns an elderly female patient who experienced second degree burn, application site peeling and application site blister while on therapy with smart relief tens therapy.The casual role assessed as possible based on temporal relationship, however, more information regarding concurrent illness, past drugs and lifestyle history can aid in comprehensive case assessment.Additionally, elderly age of the patient acts as confounder for the same.

• 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; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 6899945
• MDR Text Key: 87591903
• Report Number: 1022556-2017-00008
• 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,Followup,Followup,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Lot Number: 17E111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 73