MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number 02-01609

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported by the patient's mother that her daughter complained the device was burning her.Upon removing the device, the mother noticed burn marks on the device connectors and also small red blisters on the child's skin.She was unsure if there was an allergic reaction or if the skin appearance was from the device itself because of the burn marks on the connectors.The mother reported that the patient received medical treatment and was prescribed an ointment.The mother also expressed concern that the injury was not being taken seriously.Subsequently, additional follow-up information was received from the patent's mother stating that ointment was not prescribed, but rather an ointment was applied to skin by a school nurse.She didn't know what ointment was applied.The mother also stated that the patient did not have a known prior skin sensitivity.Alcohol wipes were used prior to applying the patch.This is related to mfr 2133409-2023-00072.

Manufacturer Narrative

It was reported that the patient got blisters and a possible allergic reaction.The sensor was returned for investigation.The sensor was investigated.Device was able to charge, and device investigation found that the temperature for the device was within normal limits.Engineering evaluation was unable to be performed as the electrode was not returned.Allegation is confirmed as the image of patient skin irritation shows 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: C6 MCOT PPM
• 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: 18148155
• MDR Text Key: 328269479
• Report Number: 2133409-2023-00071
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01609
• Device Lot Number: 02-01609
• Was Device Available for Evaluation?: No
• 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
• Treatment: UNIT, C6S 3.0, BTH, 02-01846
• Patient Age: 10 YR
• Patient Sex: Female