MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM; PATCH IN POUCH ASSY, UNIVERSAL

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing a rash while using the universal patch.The patient thought that it might be stress rash and decided to a break in service.On 11 january 2024 the patient followed-up and stated that they did seek medical attention for the rash and was prescribed triamcinolone acetonide.The patient reported that they performed a skin prep of using warm water and soap.The patient also has a history of sensitivity/allergy of mass cell activation syndrome.

• Brand Name: C6 MCOT PPM
• Common Device Name: PATCH IN POUCH ASSY, UNIVERSAL
• 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: 18586570
• Report Number: 2133409-2024-00005
• Device Sequence Number: 7049969
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01609
• Device Lot Number: U602377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female