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 Problem Local Reaction (2035)

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 complained that smart relief tens therapy (icy hot smart relief tens therapy) pads were peeling skin on her hip area around the cheek of her butt, it hurt the first day, then the second day it was worse and had red spots where the pads were pulled off.No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported.It was reported that the patients son recommend smart relief tens therapy for her erratic nerve.On (b)(6) 2017, the patient started using smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date 31-jul-2019) for erratic nerve.The electrode pad lot/batch number: b-17-01-08, expiry date: 30-sep-2019 and unit serial number was (b)(4).On the same day ((b)(6) 2017), the pads were peeling the skin on the hip area around the cheek of her butt.It hurt the first day ((b)(6) 2017), then the second day it was worse (latency same day).Reportedly, there were red spots where the pads were pulled off (onset date: (b)(6) 2017; latency same day).The patient was advised to discontinue use (date unknown).Action taken: drug withdrawn nos.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event (application site peeling).

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 11- sep-2017.This case concerns a female patient of unspecified age who complained that smart relief tens therapy (icy hot smart relief tens therapy) pads were peeling skin on her hip area around the cheek of her butt, it hurt the first day, then the second day it was worse and had red spots where the pads were pulled off.No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported.It was reported that the patients son recommend smart relief tens therapy for her erratic nerve.On (b)(6) 2017, the patient started using smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date 31-jul-2019) for erratic nerve.The electrode pad lot/batch number: b-17-01-08, expiry date: 30-sep-2019 and unit serial number was (b)(4).On the same day ((b)(6) 2017), the pads were peeling the skin on the hip area around the cheek of her butt.It hurt the first day ((b)(6) 2017), then the second day it was worse (latency same day).Reportedly, there were red spots where the pads were pulled off (onset date: (b)(6) 2017; latency same day).The patient was advised to discontinue use (date unknown).Action taken: drug withdrawn nos.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event (application site peeling).Qa review findings: received one tens unit serial number (b)(4), one panasonic battery, and one electrode lot number: 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.The pad was in bad condition but stored on a clear, protective sheet; it was dirty and had a low level of adhesion.Therefore, the consumer's complaint that the pad was difficult/painful to remove could not be verified; the consumer stated that the pad peeled skin.The left impedance readings of the pad were 470 ohms and 490 ohms, and the right impedance readings were 450 ohms and 510 ohms.Impendence readings were uniform across several pad locations; no hot spots were noted.The bad condition of the pad indicates functionality.However, the adverse event the consumer experienced could not be attributed to any device malfunction.Patient's skin was too thin for the adhesive.Additional information was received from quality department on 19-sep-2017: qa review findings were reported.Text updated accordingly.Additional information was received on 25-sep-2017 from quality department, qa review findings added.Text amended.Additional information was received on 05-oct-2017 from quality department: qa review findings updated and company causality updated from possible to unlikely.Text updated accordingly.Additional information was received on 13-dec-2017 from consumer: patient's age, weight, height and date of birth added, patient's age group was updated.Narrative was updated.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 11- sep-2017.This case concerns a female patient of unspecified age who complained that smart relief tens therapy (icy hot smart relief tens therapy) pads were peeling skin on her hip area around the cheek of her butt, it hurt the first day, then the second day it was worse and had red spots where the pads were pulled off.No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported.It was reported that the patients son recommend smart relief tens therapy for her erratic nerve.On (b)(6) 2017, the patient started using smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date 31-jul-2019) for erratic nerve.The electrode pad lot/batch number: b-17-01-08, expiry date: 30-sep-2019 and unit serial number was (b)(4).On the same day ((b)(6) 2017), the pads were peeling the skin on the hip area around the cheek of her butt.It hurt the first day ((b)(6) 2017), then the second day it was worse (latency same day).Reportedly, there were red spots where the pads were pulled off (onset date: (b)(6) 2017; latency same day).The patient was advised to discontinue use (date unknown).Action taken: drug withdrawn nos.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event (application site peeling).Qa review findings: 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.The consumer reported that the pad peeled skin when attempting to remove from site of application on hip; consumer also reported pain and redness.The pcb test data confirmed that all inspection steps were passed for control unit serial number 1612063491701 and rework was not required.Additionally, the coa confirmed that all inspection items were passed for electrode lot number b-17-01-08.Device return is expected; if/when it is returned, further investigation may be performed.Additional information was received from quality department on 19-sep-2017: qa review findings were reported.Text updated accordingly.Additional information was received on 25-sep-2017 from quality department, qa review findings added.Text amended.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 11- sep-2017.This case concerns a female patient of unspecified age who complained that smart relief tens therapy (icy hot smart relief tens therapy) pads were peeling skin on her hip area around the cheek of her butt, it hurt the first day, then the second day it was worse and had red spots where the pads were pulled off.No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported.It was reported that the patients son recommend smart relief tens therapy for her erratic nerve.On (b)(6) 2017, the patient started using smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date 31-jul-2019) for erratic nerve.The electrode pad lot/batch number: b-17-01-08, expiry date: 30-sep-2019 and unit serial number was (b)(4).On the same day ((b)(6) 2017), the pads were peeling the skin on the hip area around the cheek of her butt.It hurt the first day ((b)(6) 2017), then the second day it was worse (latency same day).Reportedly, there were red spots where the pads were pulled off (onset date: (b)(6) 2017; latency same day).The patient was advised to discontinue use (date unknown).Action taken: drug withdrawn nos.Corrective treatment: not reported.Outcome: unknown.Qa review findings: 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.Device return is expected; if/when it is returned, further investigation may be performed seriousness criteria: important medical event (application site peeling) additional information was received from quality department on 19-sep-2017: qa review findings were reported.Text updated accordingly.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 11- sep-2017.This case concerns a female patient of unspecified age who complained that smart relief tens therapy (icy hot smart relief tens therapy) pads were peeling skin on her hip area around the cheek of her butt, it hurt the first day, then the second day it was worse and had red spots where the pads were pulled off.No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported.It was reported that the patients son recommend smart relief tens therapy for her erratic nerve.On (b)(6) 2017, the patient started using smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date 31-jul-2019) for erratic nerve.The electrode pad lot/batch number: b-17-01-08, expiry date: 30-sep-2019 and unit serial number was (b)(4).On the same day ((b)(6) 2017), the pads were peeling the skin on the hip area around the cheek of her butt.It hurt the first day ((b)(6) 2017), then the second day it was worse (latency same day).Reportedly, there were red spots where the pads were pulled off (onset date: (b)(6) 2017; latency same day).The patient was advised to discontinue use (date unknown).Action taken: drug withdrawn nos corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event (application site peeling) qa review findings: received one tens unit serial number (b)(4), one panasonic battery, and one electrode lot number: 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.The pad was in bad condition but stored on a clear, protective sheet; it was dirty and had a low level of adhesion.Therefore, the consumer's complaint that the pad was difficult/painful to remove could not be verified; the consumer stated that the pad peeled skin.The left impedance readings of the pad were 470 ohms and 490 ohms, and the right impedance readings were 450 ohms and 510 ohms.Impendence readings were uniform across several pad locations; no hot spots were noted.The bad condition of the pad indicates functionality.However, the adverse event the consumer experienced could not be attributed to any device malfunction.Additional information was received from quality department on 19-sep-2017: qa review findings were reported.Text updated accordingly.Additional information was received on 25-sep-2017 from quality department, qa review findings added.Additional information was received on 05-oct-2017 from quality department: qa review findings updated and company causality updated from possible to unlikely.Text updated accordingly.

• 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: 6899928
• MDR Text Key: 87592654
• Report Number: 1022556-2017-00007
• 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: 09/11/2017

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: 10/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• 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: 83 YR
• Patient Weight: 61