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U.S. Department of Health and Human Services

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

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CHATTEM ICY HOT SMART RELIEF TENS THERAPY TRANSCUTANEOUS NERVE STIMULATOR Back to Search Results
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.
 
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Brand NameICY HOT SMART RELIEF TENS THERAPY
Type of DeviceTRANSCUTANEOUS 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 Key5415676
MDR Text Key37611555
Report Number1022556-2016-00003
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131159
Number of Events Reported1
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 Received02/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/08/2016 Patient Sequence Number: 1
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