MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC. MCOT HOLTER MONITOR; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Skin Tears (2516); Blister (4537)

Event Date 04/29/2023

Event Type  Injury  

Event Description

I was prescribed to wear an mcot(mobile cardiac outpatient telemetry) holter monitor for 14 days, to monitor heart rhythm, i was not able to complete the course.The glue used to apply the electrodes caused a blistering itching rash, upon removal it tore away my skin.This product should not be prescribed to older caucasians whose skin tears so easily.I was even supplied with " hypoallergenic " electrodes and still the same adverse reactions.Product returned to the hospital.

• Brand Name: MCOT HOLTER MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC.
• MDR Report Key: 16887650
• MDR Text Key: 314860504
• Report Number: MW5117335
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ENSURE MEAL REPLACEMENT DRINKS; EZETIMIBE; GEMIFIBROZIL; LEVOTHYROXINE; LOSARTAN
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White