MAUDE Adverse Event Report: EMERGE DIAGNOSTICS, INC. ELECTRODIAGNOSTIC FUNCTIONAL ASSESSMENT (EFA) EFA-STM; ELECTROMYOGRAPH, DIAGNOSTIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Rash (2033); Skin Tears (2516)

Event Date 06/07/2021

Event Type  Injury  

Event Description

I was tested through the company (b)(6) on site at my employer's location in (b)(6).I experienced bruising, torn skin and rashes from where the electrodes were placed and taken off my skin.The individual did not provide their name or their medical credentials but stated that the bruising, little skin tears and rash would just go away and to put a bandaid on the areas.After the test was over, i asked who could contact about the test results or if i have any questions.The tech stated that there was no one to contact and to talk to my employer.I tried to contact the company but i got their "outside" answering phone service.After the fifth call, i gave up.Fda safety report id # (b)(4).

• Brand Name: ELECTRODIAGNOSTIC FUNCTIONAL ASSESSMENT (EFA) EFA-STM
• Type of Device: ELECTROMYOGRAPH, DIAGNOSTIC
• Manufacturer (Section D): EMERGE DIAGNOSTICS, INC.
• MDR Report Key: 12583314
• MDR Text Key: 275243341
• Report Number: MW5104411
• Device Sequence Number: 1
• Product Code: IKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1