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

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Initial info regarding this serious unsolicited device case from united states was received from the pt on (b)(6) 2014.This case involving a female pt of unk age who complained that she put smart relief tens therapy (icy hot smart relief tens therapy starter kit back) on her back and it was blistered badly.No relevant medical history, past drugs, relevant concomitant medications or concurrent condition was reported.On an unk unspecified date, the pt started using smart relief tens therapy (lot/batch number and expiration date: not provided).After an unk duration of use, on a date not mentioned, she put smart relief tens therapy on her back and she complained that it was blistered.Action taken: unk.Corrective treatment: not reported.Outcome: unk.This case was assessed as serious due to medically significant event of "put this on my back and i'm blistered, bad".

Manufacturer Narrative

Pharmacovigilance comment: sanofi-aventis company comment dated (b)(4) 2014: although the causal role of icy hot smart relief tens therapy cannot be ruled out for put this on my back and i'm blistered, bad, however, the case lacks info precise dated drug history, on investigation for non-drug causes, complete medical history, concomitant medications (if any), concurrent conditions if any) to allow a more proper causality assessment.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM, INC.; chattanooga TN
• Manufacturer Contact: michael murphy ; 55 corporate drive; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089813633
• MDR Report Key: 3940206
• MDR Text Key: 16628086
• Report Number: 1022556-2014-73171
• 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: Other
• Type of Report: Initial
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• 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
• Date Manufacturer Received: 05/26/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: PREV MEDS = UNK; CON MEDS = UNK
• Patient Outcome(s): Other