MAUDE Adverse Event Report: MEDEQUIP INC. ELECTRODES; ELECTRODE, CUTANEOUS

Model Number P850090

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

Patient Problems Rash (2033); Reaction to Medicinal Component of Device (4574)

Event Type  malfunction  

Event Description

(b)(6) 2016 end user called and stated the (electrode) pad is giving her a rash on her left shoulder/arm.Looks like the measles.She is allergic to latex.Rash is only where she placed the electrodes.Note: end user was using the electrodes with a compass health brands device (acrl-3000).We originally assumed they were compass health brands electrodes, but upon evaluation of the returned devices, determined that they were: ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ELECTRODES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): MEDEQUIP INC.
• MDR Report Key: 17535712
• MDR Text Key: 321473277
• Report Number: MW5142607
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2017

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?: No
• Device Model Number: P850090
• Device Lot Number: AM000020122
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1