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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM
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ZOLL MANUFACTURING CORPORATION UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM Back to Search Results
Model Number UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Burning Sensation (2146); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Event Date 06/22/2022
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.
 
Event Description
A us distributor contacted zoll to report that the patient developed a red, burning, swollen skin irritation from the ucor hfams patch.There was no alleged device malfunction contributing to the irritation.The patient¿s physician advised to use steroid cream and temporarily remove the patch.Outcome of the skin irritation is unknown.
 
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Brand Name
UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
Type of Device
MANAGEMENT AND MONITOR SYSTEM
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA
Manufacturer Contact
zoll mfg corporation
121 gamma drive
pittsburgh, PA 15238
MDR Report Key15064985
MDR Text Key296223727
Report Number3008642652-2022-21174
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/20/2022
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 NumberUCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
Initial Date Manufacturer Received 06/23/2022
Initial Date FDA Received07/20/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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