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

Device Problem Overheating of Device (1437)

Patient Problems Abrasion (1689); Burn(s) (1757); Pain (1994)

Event Type  Injury  

Event Description

Initial information regarding this serious unsolicited device case from united states was reported by a consumer on (b)(6) 2014: this case concerns a (b)(6) male patient who burned a whole in his skin, 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 (b)(6) 2014, the patient purchased and started using the smart relief tens therapy (as instructed; lot number and expiry date: not reported).After an unspecified time, on an unknown date, it burned a hole in his skin and left him with a small, but painful abrasion.He made it clear, this it was not skin irritation.Reportedly, there were two burned areas on his lower back where he had used the device.It was reported that there were no warnings about burning with the unit.Action taken: unk.Corrective treatment: not reported.Outcome: unk.Seriousness criteria: important med 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 for event 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
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM, INC.; chattanooga TN
• Manufacturer Contact: michael murphy ; 55 corp dr; 55d-205a; bridgewater, NJ 08807 ; 9089813633
• MDR Report Key: 3913031
• MDR Text Key: 4582178
• Report Number: 1022556-2014-73194
• 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: 05/28/2014

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: PREV MEDS= UNK; CON MEDS= UNK
• Patient Outcome(s): Other
• Patient Age: 48 YR