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

Model Number 02-01609

Device Problem Biocompatibility (2886)

Patient Problems Shock (2072); Numbness (2415); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that the patient was burned on area beneath patch on the left side.The patient reported the skin was red and burn created a shock at the back of the patient's head down the left side.The patient also reported that they experienced numbness down their left side.Additional information was requested but could not be obtained.

Manufacturer Narrative

It was reported that the patient was burned under the universal patch that left the patient's skin red.The device was not returned for investigation.Engineering evaluation was unable to be performed as the electrode was not returned.Allegation is unable to be confirmed as there are no images of patient skin irritation and any skin irritation is most probable to be a bio-incompatibility issue with the electrode adhesive.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.

• 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: 18587331
• MDR Text Key: 333845314
• Report Number: 2133409-2024-00006
• 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: 04/11/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female