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

Model Number CMCV-009-MED

Device Problems Material Separation (1562); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Event 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
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC. ; roswell GA 30076
• MDR Report Key: 10648922
• MDR Text Key: 210633799
• Report Number: MW5097145
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: CMCV-009-MED
• Device Lot Number: M19D1171050
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 70