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

Lot Number 178105

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Peeling (1999); Tissue Damage (2104); Burning Sensation (2146); Burn, Thermal (2530)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

Electrode pad, lot number: b-16-09-12, exp: 05/31/2019.Serial number: (b)(4).

Event Description

This unsolicited case from united states was received on (b)(6)-2017 from the consumer.This case involves a female patient of unspecified age whose piece of skin came off and had stinging burning sensation after starting smart relief tens therapy (icy hot smart relief tens therapy back pain therapy) the patient had back surgery on l4, l5 and s1 (lower region half way over by her hip) in 1992 and again in 2001 prior to use of the device.No concomitant medications, past drugs and concurrent conditions were reported.On (b)(6) 2017, the patient commenced treatment with smart relief tens therapy (lot/batch number: 178105 and expiry date: 31-may-2019 and frequency not reported) for back pain.Electrode pad lot number: b-16-09-12 expiry date: 31-may-2019, serial number: (b)(4).The patient bought it and she used it when she got home last night between 2:30 am and 3:00 am.The reporter used the device in a rolling desk chair.The reporter touched the device and could feel the sensation.When the patient went to remove the electrode pad, she noticed a burning sensation.She also noticed a stinging burning sensation (latency: same day) after taking the device off.A piece of her skin came off (latency: same day) described as closer to the size of a dime.She had checked the electrode pad and was unable to locate the piece of skin.The reporter provided the device was placed above her butt check halfway across the spine to the hip on the right side, about where the waistline was for jeans.It was verified that the device was not placed over the spine.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown for both events.Seriousness criteria: important medical event for both events.

Manufacturer Narrative

Electrode pad lot number: b-16-09-12; exp: 05/31/2019.Serial number: (b)(4).

Event Description

This unsolicited case from united states was received on (b)(6) 2017 from the consumer.This case involves a female patient of unspecified age whose piece of skin came off and had stinging burning sensation after starting smart relief tens therapy (icy hot smart relief tens therapy back pain therapy).The patient had back surgery on l4, l5 and s1 (lower region half way over by her hip) in 1992 and again in 2001 prior to use of the device.No concomitant medications, past drugs and concurrent conditions were reported.On (b)(6) 2017, the patient commenced treatment with smart relief tens therapy (lot/batch number: 178105 and expiry date: 31-may-2019 and frequency not reported) for back pain.Electrode pad lot number: b-16-09-12 expiry date: 31-may-2019, serial number: (b)(4).The patient bought it and she used it when she got home last night between 2:30 am and 3:00 am.The reporter used the device in a rolling desk chair.The reporter touched the device and could feel the sensation.When the patient went to remove the electrode pad, she noticed a burning sensation.She also noticed a stinging burning sensation (latency: same day) after taking the device off.A piece of her skin came off (latency: same day) described as closer to the size of a dime.She had checked the electrode pad and was unable to locate the piece of skin.The reporter provided the device was placed above her butt cheek halfway across the spine to the hip on the right side, about where the waistline was for jeans.It was verified that the device was not placed over the spine.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown for both 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.The device may be returned to identify the root cause of the issues.Seriousness criteria: important medical event for both events.Additional information was received from quality department on 09-may-2017: qa review findings added.Text updated accordingly.Pharmacovigilance comment: sanofi company comment dated 15-05-2017: this case concerns a female patient who experienced exfoliation at application site whilst being on the device smart relief tens therapy.The causal role of suspect device cannot be ruled out , however, this case lacks information regarding the condition of the skin at the contact area prior to applying the device if wet, dry or open wounds and furthermore the pictures of the burn area which are yet not available would provide the comprehensive assessment of the case.

Manufacturer Narrative

Electrode pad lot number: b-16-09-12 exp: 05/31/2019.Serial number: (b)(4).

Event Description

Upon internal review on 21-aug-2017, confirmation was received on 17-aug-2017, the case (b)(4) was found to be a duplicate to the case (b)(4).Hence the case (b)(4) qualifies for deletion.All relevant information in the case (b)(4) has been merged into this case.This unsolicited case from united states was received on 20-apr-2017 from the consumer.This case involves a female patient of unspecified age whose piece of skin came off described as closer to the size of a dime (tissue damage) and had stinging burning sensation after starting smart relief tens therapy (icy hot smart relief tens therapy back pain therapy) the patient had back surgery on l4, l5 and s1 (lower region half way over by her hip) in 1992 and again in 2001 prior to use of the device.No concomitant medications, past drugs and concurrent conditions were reported.On (b)(6) 2017, the patient commenced treatment with smart relief tens therapy (lot/batch number: 178105 and expiry date: 31-may-2019 and frequency not reported) for back pain.Electrode pad lot number: b-16-09-12, expiry date: 31-may-2019, serial number: (b)(4).The patient bought it and she used it when she got home last night between 2:30 am and 3:00 am.The reporter used the device in a rolling desk chair.The reporter touched the device and could feel the sensation.When the patient went to remove the electrode pad, she noticed a burning sensation.She also noticed a stinging burning sensation (latency: same day) after taking the device off.A piece of her skin came off (latency: same day).Described as closer to the size of a dime.She had checked the electrode pad and was unable to locate the piece of skin.The reporter provided the device was placed above her butt check halfway across the spine to the hip on the right side, about where the waistline was for jeans.It was verified that the device was not placed over the spine.Patient had tissue damage, burn-thermal and burning sensation.Reportedly, the patient had a burn thermal on (b)(6) 2017, after using the smart relief tens therapy.The reporter stated the event was related to burns but was unable to provide any other information.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown for both events.Qa review was performed and investigation findings were reported as 'this product meets the monograph standard.All specifications have been met and quality reports do not reveal any issues with this product.Complaints pertaining to consumer adverse events are trended and presented to management monthly.In the absence of the product formulation, lot number, and complaint sample; no further qa investigation is possible.' seriousness criteria: important medical event for both events.Additional information was received from quality department on 09-may-2017: qa review findings added.Text updated accordingly.Upon internal review on 21-aug-2017, confirmation was received on 17-aug-2017, the case (b)(4) was found to be a duplicate to the case (b)(4).Hence the case (b)(4) qualifies for deletion.All relevant information in the case (b)(4) has been merged into this case as follows: event verbatim updated to piece of skin came off described as closer to the size of a dime (tissue damage) (formerly captured as piece of her skin came off).Text amended.Pharmacovigilance comment: sanofi company comment dated 15-05-2017: this case concerns a female patient who experienced exfoliation at application site whilst being on the device smart relief tens therapy.The causal role of suspect device cannot be ruled out , however this case lacks information regarding the condition of the skin at the contact area prior to applying the device if wet, dry or open wounds and furthermore the pictures of the burn area which are yet not available would provide the comprehensive assessment of the case.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY BACK PAIN THERAPY
• 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: 6550912
• MDR Text Key: 74590340
• Report Number: 1022556-2017-00002
• 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
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Lot Number: 178105
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other