MAUDE Adverse Event Report: ADMEDUS REGEN PTY LTD CARDIOCEL INTRACARDIAC PATCH

Device Problem Peeled/Delaminated (1454)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Excessive peel formation at the cardiocel patch implantation site in pediatric case.No significant bacterial information present.Surgeon suspected patient hypersensitivity toward materials.

• Brand Name: CARDIOCEL INTRACARDIAC PATCH
• Type of Device: INTRACARDIAC PATCH
• Manufacturer (Section D): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, western australia 6080 ; AS 6080
• Manufacturer (Section G): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, western australia 6090 ; AS 6090
• Manufacturer Contact: janel hurtado ; 860 blue gentian road; suite 340; eagan, MN 55121 ; 6514930606
• MDR Report Key: 10782255
• MDR Text Key: 214517607
• Report Number: 3012664855-2020-00014
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2020

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention