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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Sweating (2444); Palpitations (2467)
Event Date 01/03/2016
Event Type  Injury  
Event Description
Initial information regarding this unsolicited device case from united states was received from the patient on (b)(6) 2016. This case involves a male patient of unknown age, who felt a little flutter in his heart, blood pressure which was 98/53, broke out in a sweat and little woozy, same day after he started using smart relief tens therapy (icy hot smart relief tens therapy). The patient has a medical history of high blood pressure, high cholesterol and had a recent back surgery. Past drugs and concomitant medications were not reported. On (b)(6) 2016 (couple of hours ago), the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number and expiry date: unknown) for unknown indication. He stated it was working well but he then felt a little flutter in his heart, broke out in a sweat and took his blood pressure which was 98/53 on same day (onset date: (b)(6) 2016). Reportedly, on same day he still felt a little woozy. He stated he was supposed to get a spinal stimulation but wanted to try this product first. Patient was told to not use the product anymore until he speak with a physician and discussed the symptoms were concerning and these should be medically evaluated and do not drive yourself. Action taken: unknown. Corrective treatment: not reported. Outcome: unknown. Seriousness criteria: important medical event of felt a little flutter in his heart and bp which was 98/53. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2016: this case concerns a male patient who experienced palpitation and blood pressure decreased while using the device smart relief tens. The causal role of suspect device cannot be formally excluded, however the medical history of patient may be a plausible factor for the occurrence of the events.
 
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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 Key5359627
MDR Text Key35623232
Report Number1022556-2016-00001
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
PMA/PMN Number
K131159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 01/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/12/2016 Patient Sequence Number: 1
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