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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Shock (2072)

Event Type  Injury  

Event Description

This serious unsolicited device case from united states was received on (b)(6) 2014 from the patient.This case involves a male patient of unknown age who felt a shock after an unknown duration of commencing smart relief tens therapy (icy hot smart relief tens therapy starter kit back).The patient had a significant medical history of hip replacement.No relevant past drugs, relevant concomitant medications or concurrent condition was reported.On a date not specified, the patient started to use smart relief tens therapy.The patient had a hip replacement which contains metal and uses smart relief tens therapy (device use error).After an unknown duration of use, on a date not mentioned, he has felt a shock when repositioning the pad before.Action taken: unk.Corrective treatment: not reported.Outcome: unk.The case was assessed as serious due to an important medical event of "felt a shock".

• 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: 3940208
• MDR Text Key: 4577180
• Report Number: 1022556-2014-75636
• 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: 06/02/2014

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: 06/02/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: CON MEDS: UNK; PREV MEDS: UNK
• Patient Outcome(s): Other