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

Model Number 02-01609

Device Problem Biocompatibility (2886)

Patient Problem Rash (2033)

Event Date 12/21/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 333839678
• Report Number: 2133409-2024-00005
• 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
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 02-01609
• Device Lot Number: U602377
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female