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

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

Patient Problem Local Reaction (2035)

Event Type  Injury  

Event Description

Initial information regarding this unsolicited case from united states was received on (b)(6)2017 from patient's wife.This case involves a male patient of unknown age, who ended up with 2 blisters on his back after receiving treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy).Past drugs, medical history and concomitant medications were not reported.On (b)(6)2017, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/ batch number and expiry date: unknown) for hurting back.It was reported that patient used smart relief tens therapy for a bit that day ((b)(6)2017) and he ended up with 2 blisters on his back (onset date and latency: unknown).Action taken: unknown.Corrective treatment: not reported.Event outcome: unknown.Seriousness criteria: important medical event: a product technical complaint (ptc) was initiated with local ptc number: (b)(4).

Event Description

Initial information regarding this unsolicited case from united states was received on 04-aug-2017 from patient's wife.This case involves a male patient of unknown age, who ended up with 2 blisters on his back after receiving treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy).Past drugs, medical history and concomitant medications were not reported.On (b)(6) 2017, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/ batch number and expiry date: unknown) for hurting back.It was reported that patient used smart relief tens therapy for a bit that day ((b)(6) 2017) and he ended up with 2 blisters on his back (onset date and latency: unknown).Action taken: unknown.Corrective treatment: not reported.Event outcome: unknown.Seriousness criteria: important medical event.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.Device return is expected; if/when it is returned further investigation may be performed.Additional information was received from the quality department on 07-aug-2017: qa review findings were added.Text updated accordingly.

• Brand Name: ICY HOT SMART RELIEF TENS 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: 6805849
• MDR Text Key: 83096241
• Report Number: 1022556-2017-00005
• 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
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• 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