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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE; MESH, SURGICAL
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AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE; MESH, SURGICAL Back to Search Results
Model Number CMCV-009-XLG
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)
Date of Event 10/04/2019
Type of Reportable Event Serious Injury
Additional 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 or Problem 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.
 
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Brand Name
CANGAROO ENVELOPE
Common Device Name
MESH, SURGICAL
Manufacturer (Section D)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell, ga
MDR Report Key9781359
Report Number3005619880-2020-00021
Device Sequence Number14116022
Product Code FTM
UDI-Device Identifier00859389005072
UDI-Public00859389005072
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K182255
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberCMCV-009-XLG
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/05/2020
Initial Report FDA Received Date03/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
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