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

CHATTEM SMART RELIEF TENS THERAPY KNEE AND SHOULDER; TRANSCUTANEOUS NERVE STIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/16/2016

Event Type Injury

Event Description

Initial information regarding this unsolicited device case from united states was received from a healthcare professional (a patient itself) on (b)(6) 2016.This case involves a female patient of unknown age, whose back was burned and blistered (burn was right near the left side of the spine), had application site paresthesia (tingling) and application site scab (wound was starting to scab), unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).No information about past drugs were reported.On unknown date in (b)(6) 2016, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number with expiry date: unknown; control unit serial number: (b)(4)) for spine ruptured pain.Patient stated her spine ruptured a while ago and this was the most pain she had in 6 years.She stated she bought device around noon on (b)(6) 2016 along with refill kit as she had strained a muscle in my lower back and into the left hip.She never used this device before.She had just used the regular icy hot for pain (concomitantly use).Reportedly, the unit was on the lowest setting/ first intensity level for 30 minutes.She did not have any icy hot product on her skin when she applied the pad as she had taken a shower and was putting on clean skin.In the middle of the first cycle which was on lowest setting, she felt as though her skin was tingling (onset date: (b)(6) 2016; latency unknown) and burning.She adjusted the pad slightly to the left while still on the first cycle and could no longer take the stinging.She removed the pad and was in serious pain from the burns.As the night went on the appearance of the burns and the pain worsened.Her back was burned and blistered (onset date: (b)(6) 2016; latency: unknown).She had never used any product such as icy hot or a heating pad after applying the pad to her skin.She could not sleep because her back hurts; also hurts when she takes a showers and sleeping and sitting was painful.Reportedly, when she used the device (smart relief tens therapy) made her back so much more worse.She stated she could not use the heating paid or the regular icy hot she used before buying smart relief tens therapy.She was still in alot of pain with the muscle pull and burns and went to the emergency room (er) on (b)(6) 2016.She went to er for pain in her back not for the burn.The burn was right near the left side of the spine on her back.The doctor treated her and she was recommend to use cold soaks on her back and vaseline as she had the burn and the wound started to scab (onset date and latency unknown) and was itching which meant it was healing and would take time to go away.She recommended cool compresses instead of hot due to the burns.Patient stated she said to her husband it felt like a really bad sun burn.She stated this was hindering her recovery and recovery was taking a little longer.Action taken: permanently discontinued in (b)(6) 2016.Corrective treatment: not reported for application site scab and application site paresthesia.Outcome: not reported.Seriousness criteria: important medical event for both the events.Qa review findings: 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.Awaiting device return for additional investigation.Additional information was received from the quality department on 17-oct-2016, 18-oct-2016, 19-oct-2016, 20-oct-2016 and 21-oct-2016 (all information processed together with csd of 17-oct-2016): events added application site scab and application site paresthesia added, symptom of stinging, itching and redness added, corrective treatment added and action taken updated from drug withdrawn nos to permanently discontinued.Text updated accordingly.

Event Description

Initial information regarding this unsolicited device case from united states was received from a healthcare professional (a patient itself) on 17-oct-2016.This case involves a female patient of unknown age, whose back was burned and blistered (burn was right near the left side of the spine), had application site paresthesia (tingling) and application site scab (wound was starting to scab), unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).No information about past drugs was reported.On unknown date in (b)(6) 2016, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number with expiry date: unknown; control unit serial number: (b)(4)) for spine ruptured pain.Patient stated her spine ruptured a while ago and this was the most pain she had in 6 years.She stated she bought device around noon on (b)(6) 2016 along with refill kit as she had strained a muscle in my lower back and into the left hip.She never used this device before.She had just used the regular icy hot for pain (concomitantly use).Reportedly, the unit was on the lowest setting/first intensity level for 30 minutes.She did not have any icy hot product on her skin when she applied the pad as she had taken a shower and was putting on clean skin.In the middle of the first cycle which was on lowest setting, she felt as though her skin was tingling (onset date: (b)(6) 2016; latency unknown) and burning.She adjusted the pad slightly to the left while still on the first cycle and could no longer take the stinging.She removed the pad and was in serious pain from the burns.As the night went on the appearance of the burns and the pain worsened.Her back was burned and blistered (onset date: (b)(6) 2016; latency: unknown).She had never used any product such as icy hot or a heating pad after applying the pad to her skin.She could not sleep because her back hurts; also hurts when she takes a showers and sleeping and sitting was painful.Reportedly, when she used the device (smart relief tens therapy) made her back so much more worse.She stated she could not use the heating paid or the regular icy hot she used before buying smart relief tens therapy.She was still in a lot of pain with the muscle pull and burns and went to the emergency room (er) on (b)(6) 2016.She went to er for pain in her back not for the burn.The burn was right near the left side of the spine on her back.The doctor treated her and she was recommend to use cold soaks on her back and vaseline as she had the burn and the wound started to scab (onset date and latency unknown) and was itching which meant it was healing and would take time to go away.She recommended cool compresses instead of hot due to the burns.Patient stated she said to her husband it felt like a really bad sun burn.She stated this was hindering her recovery and recovery was taking a little longer.She had to go back to the doctor to get a prescription cream for the burn.The burn was on her back area where she buttons her pants.It was a really bad burn and had hindered her recovery.When she sits down the wombs reopen, no hot water could touch the womb.The burn was almost gone.Also she reported that the burn was in the scaly and itchy stage and it felt like sand paper.Also, the doctor gave her a prescription for 1 mint silver sulfadiazine twice a day.She also stated that the area for burn was so big that the doctor had to do a refill which they normally did not do.Action taken: permanently discontinued in (b)(6) 2016 corrective treatment: not reported for application site scab and application site paresthesia.Outcome: recovering for application site burn.Unknown for other events seriousness criteria: important medical event for application site burn and application site blister qa review findings: 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.Awaiting device return for additional investigation.Additional information was received from the quality department on 17-oct-2016, 18-oct-2016, 19-oct-2016, 20-oct-2016 and 21-oct-2016 (all information processed together with csd of 17-oct-2016): events added application site scab and application site paresthesia added, symptom of stinging, itching and redness added, corrective treatment added and action taken updated from drug withdrawn nos to permanently discontinued.Text updated accordingly.Follow-up information was received on 24-oct-2016: no new information was received.Additional information was received on 24-oct-2016, 27-oct-2016 and 28-oct-2016 (all information processed together with csd of 27-oct-2016): the outcome for application site burn and corrective updated.Information regarding event was added and text updated accordingly.Pharmacovigilance comment: sanofi company comment dated 03-11-2016: this case involves an adult female patient who reported application site blistered while on treatment with smart relief tens therapy.Although the causal role of the drug cannot be denied for the reported events, however lack of information of latency, any preexisting injury over the application site, concurrent medical condition and personal history preclude a comprehensive assessment in this case.

Event Description

Initial information regarding this unsolicited device case from united states was received from a healthcare professional (a patient itself) on 17-oct-2016.This case involves a (b)(6) female patient, whose back was burned and blistered (burn was right near the left side of the spine), had application site paresthesia (tingling) and wound was starting to scab and scar on back, unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).Concurrent conditions: hypertension, allergic rhinitis, anxiety, asthma, bipolar 1 disorder, carpal tunnel syndrome, chemical burn of trunk, chronic lower back pain, congenital septal defect of heart, cough present for greater than 3 weeks, depression, fatigue, folliculitis, hives, hyperlipidemia, knee pain, major depressive episode, microalbuminuria, nausea, post concussion syndrome, urticaria, ventricular septal defect, vertigo.Medical history: acute sinusitis, head injury, sprain of wrist, rectal hemorrhage, urinary tract infection, spinal discectomy, patient had surgery for cauda equina 6 years ago and did have complications during surgery which included a brain bleed-caused memory deficits and dizziness at times: carpal tunnel, anxiety.Patient denied history of alcohol use and patient was non-smoker.Concomitant medications: alprazolam, atenolol, escitalopram oxalate, lamotrigine, montelukast sodium, salbutamol sulfate (proair hfa), simvastatin and trazodone hydrochloride it was reported that patient was doing tricks with her hula hoop and pulled her back.The pain was so severe that she had trouble walking and moving around.On unknown date in (b)(6) 2016, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number with expiry date: unknown; control unit serial number: (b)(4)) for spine ruptured pain.Patient had pain in lower back and pain radiation location was lower hip.The pain effected sleep and alleviating factors for pain were reported as: banding to pick something up, rising from chair, lifting leg into bed or scooting in bed, sitting for a long time and standing for a long time.Patient stated her spine ruptured a while ago and this was the most pain she had in 6 years.She stated she bought device around noon on (b)(6) 2016 along with refill kit as she had strained a muscle in my lower back and into the left hip.She never used this device before.She had just used the regular icy hot for pain (concomitantly use).Reportedly, the unit was on the lowest setting/first intensity level for 30 minutes.She did not have any icy hot product on her skin when she applied the pad as she had taken a shower and was putting on clean skin.In the middle of the first cycle which was on lowest setting, she felt as though her skin was tingling (onset date: (b)(6) 2016; latency unknown) and burning.She adjusted the pad slightly to the left while still on the first cycle and could no longer take the stinging.She removed the pad and was in serious pain from the burns.As the night went on the appearance of the burns and the pain worsened.Her back was burned and blistered (onset date: (b)(6) 2016; latency: unknown).She had never used any product such as icy hot or a heating pad after applying the pad to her skin.She could not sleep because her back hurts; also hurts when she takes a showers and sleeping and sitting was painful.Reportedly, when she used the device (smart relief tens therapy) made her back so much more worse.She stated she could not use the heating paid or the regular icy hot she used before buying smart relief tens therapy.She was still in a lot of pain with the muscle pull and burns and went to the emergency room (er) on (b)(6) 2016.She went to er for pain in her back not for the burn.The burn was right near the left side of the spine on her back.The doctor treated her and she was recommend to use cold soaks on her back and vaseline as she had the burn and the wound started to scab (onset date and latency unknown) and was itching which meant it was healing and would take time to go away.She recommended cool compresses instead of hot due to the burns.Patient stated she said to her husband it felt like a really bad sun burn.She stated this was hindering her recovery and recovery was taking a little longer.Patient had scar on back from tens site about 8 cm x 12 cm.She had to go back to the doctor to get a prescription cream for the burn.The burn was on her back area where she buttons her pants.It was a really bad burn and had hindered her recovery.When she sits down the wombs reopen, no hot water could touch the womb.The burn was almost gone.Also she reported that the burn was in the scaly and itchy stage and it felt like sand paper.Also, the doctor gave her a prescription for 1 mint silver sulfadiazine twice a day.She also stated that the area for burn was so big that the doctor had to do a refill which they normally did not do.Action taken: permanently discontinued in (b)(6) 2016 corrective treatment: not reported for application site scab and application site paresthesia.Outcome: recovering for application site burn.Unknown for other events.Seriousness criteria: important medical event for application site burn and application site blister.Qa review findings: 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.Awaiting device return for additional investigation.Additional information was received from the quality department on 17-oct-2016, 18-oct-2016, 19-oct-2016, 20- oct-2016 and 21-oct-2016 (all information processed together with csd of 17-oct-2016): events added application site scab and application site paresthesia added, symptom of stinging, itching and redness added, corrective treatment added and action taken updated from drug withdrawn nos to permanently discontinued.Text updated accordingly.Follow-up information was received on 24-oct-2016: no new information was received.Additional information was received on 24-oct-2016, 27-oct-2016 and 28-oct-2016 (all information processed together with csd of 27-oct-2016): the outcome for application site burn and corrective updated.Information regarding event was added and text updated accordingly.Follow-up information was received on 06-nov-2016 from a consumer: no new information was received.Follow-up information was received on 18-nov-2016 from a consumer: no new information was received.Additional information was received on 03-mar-2017 from hcp: age of patient added, medical history, concurrent conditions and concomitant medications added.Onset of application site burn updated.Event verbatim for application site scab updated.Clinical course was updated.Pharmacovigilance comment: sanofi company comment for follow up dated 03-03-2017: this case concerns a (b)(6) female patient who reported application site blister while on treatment with smart relief tens therapy.Although the causal role of the drug cannot be denied for the reported events, however lack of information of latency, past drugs and personal history preclude a comprehensive assessment in this case.Additionally, patient's medical history of chemical burn of trunk, folliculitis act as confounders for the same.

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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

heather schiappacasse

55 corporate drive

55b-220a

bridgewater, NJ 08807

9089817289

MDR Report Key

6059933

MDR Text Key

58504337

Report Number

1022556-2016-00006

Device Sequence Number

Product Code

NUH

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K131159

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,health professional

Reporter Occupation

Health Professional

Type of Report

Initial,Followup,Followup,Followup

Report Date

10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

10/27/2016

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Lay User/Patient

Is the Reporter a Health Professional?

Yes

Date Manufacturer Received

03/03/2017

Was Device Evaluated by Manufacturer?

Yes

Is the Device Single Use?

Type of Device Usage

Patient Sequence Number

Treatment

ICY HOT(CON.)

Patient Outcome(s)

Other;

Patient Age

49 YR

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

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