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

Lot Number 14A101

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

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Initial info regarding unsolicited serious device case from united states was received from a consumer on (b)(6) 2014.This case involves a female pt of unk age who experienced second degree burn on her back and her back was permanently scarred an unspecified time frame after stating device therapy with smart relief tens therapy ((b)(6) smart relief tens therapy).Medical history: the pt had severe back pain from 3 years after the birth of her child.Concomitant medications: not reported.On an unk date, the pt commenced treatment with smart relief tens therapy at an unk dosage regimen (lot number 14a101 and exp date: unk) for back pain.Later, on an unspecified date when the pt was in the shower and the area where the pad was burned when the water hit it.But at the time, she thought that was just because it was sensitive and that a part of the "therapy".But all day long the area still burned, and it felt like it was increasing in pain.She could not see anything because it was in the middle of her back.The next day the pain in the area where the pad continued to burn.She reached back and she could feel it was rough.She asked friend to look at her back to see some of the gel from the pad was still on her back, that was when she discovered that she had a second degree burn (date of onset: unk).On an unspecified date, her back was permanently scarred.Action taken: unk.Corrective treatment: not reported.Outcome: unk.Seriousness: medically significant.

Manufacturer Narrative

Pharmacovigilance comment: sanofi-aventis company comment dated (b)(4) 2014: although the causal role of (b)(6) smart relief tens therapy cannot be excluded for the event of second degree burn on my back, my back is permanently scarred; however, lack of info regarding the time interval for which the product was used by the pt on his back limits the comprehensive assessment of the case.

• 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 dr; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089813633
• MDR Report Key: 3890813
• MDR Text Key: 21733220
• Report Number: 1022556-2014-68814
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 14A101
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/04/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: PREV MEDS = UNK; CON MEDS = UNK
• Patient Outcome(s): Other