MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE; MESH, SURGICAL

Model Number	CMCV-009-XLG
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Canganroo pouch disintegrated on attempted insertion into aicd (automatic implantable cardiac defibrillator) pocket.After abx (antibiotic) soak.Removed intact.No patient harm.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis rd suite 1200; roswell GA 30076
• MDR Report Key: 13450681
• Report Number: 13450681
• Device Sequence Number: 6199458
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: (01)00859389005072(17)221106(10)M20M1348034
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/01/2022
• Report Date (Section F): 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M20M1348034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White
• Date Report Sent to FDA: 02/01/2022