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

Model Number CMCV-009-LRG

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the device history record for the reported lot shows that all units were quality released on 10-sep-2019 having met all internal qc acceptance requirements.All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release.There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.It can be noted that per the instructions for use [ifu] (part number-20663 provided with device) for the cangaroo envelope currently lists infection as a potential complication associated with the procedure and device.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication with the cangaroo envelope.

Event Description

Product was part of a system revision due to infection and erosion.Reportedly, the patient had an open suture line leading to infection with hematoma.The pocket was irrigated with antibiotic solution after removal of the device.There were no additional adverse patient effects reported.The product was explanted.

• Brand Name: CANGAROO ENVELOPE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• Manufacturer (Section G): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• Manufacturer Contact: andrew green ; 1100 old ellis road; ste 1200; roswell, ga
• MDR Report Key: 9734515
• MDR Text Key: 191914009
• Report Number: 3005619880-2020-00028
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M19K1383085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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
• Patient Age: 42 YR