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

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Initial information regarding this serious unsolicited device case from the united states was received from a healthcare professional reporter (pharmacist) on (b)(4) 2016.This case involves a patient of unknown demographics who had a serious skin reaction, unknown duration after starting smart relief tens therapy (icy hot smart relief tens therapy).Relevant past medications, medical history or concomitant medications were not reported.On an unspecified date, the patient started using smart relief tens therapy for an unreported indication (lot/ batch number and expiration date: not provided).The patient had a serious skin reaction, unknown time after starting the use of smart relief tens therapy (onset date: unknown) and the reporter was trying to determine the ingredient in the product that caused the event.Action taken: unknown.Information on corrective treatment was not provided.Outcome: unknown.This case was assessed as serious due to medically significant event of "had a serious skin reaction".

Event Description

Initial information regarding this serious unsolicited device case from the united states was received from a healthcare professional reporter (pharmacist) on (b)(6) 2016.This case involves a patient of unknown demographics who had a serious skin reaction, unknown duration after starting smart relief tens therapy (icy hot smart relief tens therapy).Relevant past medications, medical history or concomitant medications were not reported.On an unspecified date the patient started using smart relief tens therapy for an unreported indication (lot/ batch number and expiration date: not provided).The patient had a serious skin reaction, unknown time after starting the use of smart relief tens therapy (onset date: unknown) and the reporter was trying to determine the ingredient in the product that caused the event.Action taken: unknown.Information on corrective treatment was not provided.Outcome: unknown.Qa review was performed and investigation findings were reported as "the device history files were reviewed at the time of the complaint 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." this case was assessed as serious due to medically significant for the event of "had a serious skin reaction".Additional information was received on 29-jan-2016: qa review was added.Text amended accordingly.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM; 1715 west 38th street; chattanooga TN 37409
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5415676
• MDR Text Key: 37611555
• Report Number: 1022556-2016-00003
• 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: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• 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?: Yes
• Date Manufacturer Received: 01/29/2016
• 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