MAUDE Adverse Event Report: CHATTEM, INC. ICY HOT SMART RELIEF TENS THERAPY (SMART RELIEF TENS THERAPY); TRANSCUTANEOUS NERVE STIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Initial information regarding this serious unsolicited device case from (b)(6) was reported by a consumer via social media on (b)(6) 2014: this case concerns a patient of unspecified demography who got burned, an unspecified time after starting therapy with smart relief tens therapy (icy hot smart relief tens therapy).No past drugs, relevant medical history, concomitant medications and concurrent conditions were reported.On an unknown date, the patient started using smart relief tens therapy (lot number and expiry date: not reported).After an unspecified time, on an unknown date, the patient just got burned with smart relief tens therapy which literally burned a hole into the patient's skin.It was reported that there were no warnings or caution about that.Action taken: unk.Corrective treatment: not reported.Outcome: unk.Seriousness criteria: important medical event.

Manufacturer Narrative

Pharmacovigilance comment: sanofi-aventis company comment dated (b)(4) 2014: although the casual role of smart relief tens therapy cannot be ruled out forgot burned however, the case lacks information on the underlying condition, time period for which company product was used, precise dated drug history, on investigations for non-drug causes, complete medical history, concommitant medications (if any) to allow a more proper casuality assessment.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY (SMART RELIEF TENS THERAPY)
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM, INC.; chattanooga TN
• Manufacturer Contact: micahel murphy ; 55 corporate dr; 55d-205a; bridgewater, TN 08807 ; 9089813633
• MDR Report Key: 3913026
• MDR Text Key: 21526587
• Report Number: 1022556-2014-75238
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• PMA/PMN Number: K131159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 05/30/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: PREV MEDS= UNK; CON MEDS= UNK
• Patient Outcome(s): Other