MAUDE Adverse Event Report: THE PROMETHEUS GROUP PATHWAY VAGINAL EMG/STIMULATION; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Lot Number (10)220314

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Patient was receiving electric stimulation for functional stim strengthening of the pelvic floor when pt screamed out-loud that the machine was "burning her." i immediately pulled the probe cord from the machine to disconnect the electric stimulation.Fda safety report id # (b)(4).

• Brand Name: PATHWAY VAGINAL EMG/STIMULATION
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): THE PROMETHEUS GROUP; dover NH 03820
• MDR Report Key: 14676964
• MDR Text Key: 294058673
• Report Number: MW5110278
• Device Sequence Number: 1
• Product Code: KPI
• 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: 06/09/2022

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 Operator: Health Professional
• Device Lot Number: (10)220314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White