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

Model Number	CMCV-009-MED
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
This was an initial implant of a pacemaker: the scrub tech opened and prepared the equipment per manufacturer's instructions while in the room with the physician.After the preparation time, the device pouch was handed to the implanting physician.At this time the physician attempted to open the device for use.The sutures that are attached to the device in packaging began to dissolve/fall away from the pouch opening.Subsequently, the pouch separated on itself and was not deemed usable.Fda safety report id# (b)(4).

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC. ; roswell GA 30076
• MDR Report Key: 10648922
• Report Number: MW5097145
• Device Sequence Number: 3529467
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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 Expiration Date: 09/26/2021
• Device Model Number: CMCV-009-MED
• Device Lot Number: M19D1171050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 70