MAUDE Adverse Event Report: DJO, INC. DURA SITCK PLUS SELF-ADHESIVE TENS/NMES/FES STIMULATING ELECTRODES; ELECTRODE, CUTANEOUS

Model Number 42182

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  malfunction  

Event Description

Physical therapist was removing dura-stick electrodes from patient and noticed that the lead from one specific electrode was compromised.The lead pulled away completely from the adhesive.Patient was not harmed during treatment.

• Brand Name: DURA SITCK PLUS SELF-ADHESIVE TENS/NMES/FES STIMULATING ELECTRODES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): DJO, INC.; carlsbad CA 92010
• MDR Report Key: 19051618
• MDR Text Key: 339629020
• Report Number: MW5153572
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 42182
• Device Lot Number: 316096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White