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

Model Number CMCV-009-XLG

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

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Device lot number is unknown.Manufacturing review of the device history record cannot be conducted.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication with the cangaroo envelope as stated in the ifu provided with the device.

Event Description

It was reported that this product was part of a system explant due to infection and erosion with sepsis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.This product was explanted.Report states aziyo product not related to event.

• 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: 9781359
• MDR Text Key: 188138931
• Report Number: 3005619880-2020-00021
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMCV-009-XLG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• 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
• Patient Age: 76 YR