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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT UNIVERSAL PATCH; C^MCOT UNIVERSAL PATCH

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BRAEMAR MANUFACTURING, LLC C6 MCOT UNIVERSAL PATCH; C^MCOT UNIVERSAL PATCH Back to Search Results
Model Number 02-01609
Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)
Patient Problems Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)
Event Date 01/31/2023
Event Type  Injury  
Manufacturer Narrative
Patient reported open, wet, and bleeding blisters.Skin was prepped by washing with warm water, soap and dried.Patient went to er, cortisone cream applied.Patient wore monitor for 5 days and had to remove due to the skin irritation.Patient returned the monitor, but did not return the patch which is what caused the skin issue.Patient discontinued service.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.
 
Event Description
Patient reported open, wet, and bleeding blisters.Skin was prepped by washing with warm water, soap and dried.Patient went to er, cortisone cream applied.Patient wore monitor for 5 days and had to remove due to the skin irritation.Patient returned the monitor, but did not return the patch which is what caused the skin issue.Patient discontinued service.
 
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Brand Name
C6 MCOT UNIVERSAL PATCH
Type of Device
C^MCOT UNIVERSAL PATCH
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
1285 corporate center drive
suite 150
eagan MN 55121
Manufacturer (Section G)
BRAEMAR MANUFACTURING, LLC
1285 corporate center dr
suite 150
eagan MN 56121
Manufacturer Contact
beverly okoh
1285 corporate center drive
suite 150
eagan, MN 55121
6124263781
MDR Report Key16401162
MDR Text Key309863669
Report Number2133409-2023-00004
Device Sequence Number1
Product Code DSI
UDI-Device IdentifierB146PE20
UDI-PublicB146PE20
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/17/2023
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 Number02-01609
Device Lot NumberP201496
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/31/2023
Initial Date FDA Received02/17/2023
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
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age93 YR
Patient SexFemale
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