MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM PRIMARY CARE BY MDP ECG MONITORING ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Model Number REF V8850

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Peeling (1999); Skin Irritation (2076); Burning Sensation (2146); Discharge (2225); Reaction (2414)

Event Date 05/11/2020

Event Type  Injury  

Event Description

Skin reaction (welts, rash, itching, oozing, burning pain) to electrodes used for a 14 day holter monitor.The monitoring company sent me these electrodes stating they were for sensitive skin.I changed the electrodes and move them to a new place every 24 hours.Two weeks after completing my monitoring i still have dry peeling skin.I can provide pictures of the skin reaction.Fda safety report id #: (b)(4).

• Brand Name: PRIMARY CARE BY MDP ECG MONITORING ELECTRODES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM
• MDR Report Key: 10100861
• MDR Text Key: 193313544
• Report Number: MW5094742
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF V8850
• Device Lot Number: 46519V25
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 70