MAUDE Adverse Event Report: TENS PLUS INDUSTRIAL COMPANY TENS; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Model Number AWQ-104LT DIGITAL

Device Problems Output Problem (3005); Positioning Problem (3009)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2022

Event Type  malfunction  

Event Description

The intensity knob on the e-stim machine appeared to be in the off position; however, the knob is no longer seated correctly and was actually turned up very high.When the therapist applied the electrical stimulation to the patient's right posterior shoulder and right upper trapezius, he received a brief high-intensity electrical stimulus.The therapist immediately turned off the e-stim and continued dry needling treatment manually.Patient reported some mild soreness post-treatment that is normal following dry needling.No obvious injury observed.

• Brand Name: TENS
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): TENS PLUS INDUSTRIAL COMPANY; 230 libbey pkwy; east weymouth MA 02189
• MDR Report Key: 15885303
• MDR Text Key: 304510199
• Report Number: 15885303
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AWQ-104LT DIGITAL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12775 DA
• Patient Sex: Male