MAUDE Adverse Event Report: INTENSITY10 TENS UNIT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Nerve Damage (1979); Paralysis (1997); Electric Shock (2554)

Event Date 06/16/2015

Event Type  Injury  

Event Description

Physical therapist (b)(6) was turning off tens unit when it malfunctioned and electrocuted me.She had to remove the batteries to get it to stop.Resulted in burns and increased paralysis, nerve damage.Analgesic healthcare.

• Brand Name: INTENSITY10 TENS UNIT
• Type of Device: INTENSITY10 TENS UNIT
• MDR Report Key: 4994471
• MDR Text Key: 25241555
• Report Number: MW5055291
• Device Sequence Number: 1
• Product Code: NUH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 200