MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MCOT BIOTEL HEART; DETECTOR AND ALARM, ARRHYTHMIA

Patient Problems Pain (1994); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 04/13/2024

Event Type  Injury  

Event Description

Pt presented to ed at (b)(6) medical center in (b)(6) with history of acute onset of burning to anterior chest wall from wireless holter monitor that she was unable to remove.Pt was sitting at a stop light driving home from work and felt acute onset of burning to here chest at the site of a wireless holter monitor adhered with a large tegaderm.Pt states that she touched monitor found it to be hot to the touch and pain spreading.Pt was unable to remove the device as "the plastic tape would not come off and was still burning" so came to the ed directly.Upon arrival, triage nursing staff found device still very warm and were unable to remove the tegaderm as seemed that the edges were seemed inverted into the skin and not visible.This physician called to triage and curved hemostat used to access an edge and remove tegaderm which was very tightly adhered to skin.Pt sustained area of burn approx 5cm x 8 cm ( (approx 1.5-2% bsa) with lose of dermal layer of skin ( 1cm in 1/2 moon shape)at the superior aspect of the device.Area was painful but did have some areas of insensate skin from the mid to distal portion of injured skin.Images of affected area placed in patients chart.Pt discharged with pain medications, silvadene cream, and general surgery covering for plastics ( dr.(b)(6)) was consulted and he agreed to follow-up patient on (b)(6) 2024.Device placed in biohazard bag after removed, sealed, pt medical sticker attached and was given to the patient.Patient contacted customer rep for device company and was told she would be contacted as soon as possible by a supervisor.Reference report: mw5153977.

• Brand Name: MCOT BIOTEL HEART
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 19142136
• MDR Text Key: 340673872
• Report Number: MW5153976
• 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: Patient
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Patient Sequence Number: 1
• Treatment: ALBUTEROL.; ALLEGRA.; BCP.; EPI PEN.; FLONASE.; IMITREX.; LODINE.; MDI.; SINGULAR.
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American