MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 900-0634-00

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Local Reaction (2035); Tissue Breakdown (2681); Blister (4537); Skin Burning Sensation (4540)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

Patient reported a burning sensation under patches of an event recorder.Patient was instructed to remove the patches.Patient sent pictures of area under patches which was with blisters as well as being open areas.Patient was unable to complete study.Events were reported to our biotel representative, with little response from the company.Of note, this is 1 of 3 patients who have had this reaction at our facility.

• Brand Name: MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 55121
• MDR Report Key: 11789693
• MDR Text Key: 249459679
• Report Number: 11789693
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 900-0634-00
• Device Catalogue Number: 900-0634-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2021
• Event Location: Other
• Date Report to Manufacturer: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA