MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIVERSAL PATCH; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 02-01609

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

Patient Problems Rash (2033); Blister (4537)

Event Type  Injury  

Event Description

The patient's parent reported that on the first day of wearing the holter monitor the patient was experiencing discomfort.On the second day tiny red dots were noted on the patient's skin.By the third day the patient was in pain and there was a large mark/gash that looked like burns.The patient's parent removed the device and later noticed lumps and a developing rash that required several urgent care runs and a trip to the emergency room (er).The patient was treated for a staph infection and was prescribed two types of antibiotics, one topical and anti fungal which was oral for three months.The patient is no longer on service.The patient has a history of eczema.

Manufacturer Narrative

It was reported that the patient was experiencing discomfort due to the device overheating and potentially burning them.The device was not returned.The reported adverse event is confirmed through the need for a prescription.The reported malfunction could not be confirmed as the device was not provided for evaluation, therefore investigation results are inconclusive.A definitive root cause could not be determined.

• Brand Name: UNIVERSAL PATCH
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 17427612
• MDR Text Key: 320078413
• Report Number: 2133409-2023-00042
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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?: No
• Device Model Number: 02-01609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 4 YR
• Patient Sex: Male