MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITORING SYSTEM

Model Number Patch

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

Patient Problem Skin Irritation (2076)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.

Event Description

A zoll laboratory services contacted zoll to report that a patient developed severe blistering under the patches.The area was red and raised, with broken skin.The patient reported that the area was itching and burning.There was no alleged device malfunction contributing to the irritation.Patient was keep the patch off by a physician.Outcome of the irritation is unknown.

• Brand Name: UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
• Type of Device: MANAGEMENT AND MONITORING SYSTEM
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: anna beatty ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10408448
• MDR Text Key: 202962058
• Report Number: 3008642652-2020-06977
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00855778005258
• UDI-Public: 00855778005258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2020

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: Patch
• Device Catalogue Number: 10A1067
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR