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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL-FTM Back to Search Results
Model Number CMCV-009-XLG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
No sample was returned for evaluation. Manufacturing review of the referenced lot number and respective device history record was conducted on 8sep2021, showing that all units were quality released on 13apr2021 having met all internal qc acceptance requirements. There was one non-conformance associated with the manufacturing lot during the final packaging which was addressed through a nonconforming materials report. It was resolved and was unrelated to the reported adverse event. Sterile subassembly lot m20m1337 (prt-20679-09) was also reviewed for potential issues impacting the quality of this product. This subassembly lot was released to component inventory on 30nov2020 having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements. In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing. It is also noted that per the instructions for use (ifu - art-20662c) provided with the finished cangaroo envelope device, "inflammation" is listed as a potential complication associated with this procedure and device usage.
 
Event Description
On (b)(6) 2021 a patient had an icd change out procedure which included an aziyo biologics cangaroo envelope model cmcv-009-xlg lot number m21d1130. On (b)(6) 2021 the patient had a pocket revision procedure performed due to redness and swelling at the site of the pocket revision. Remnants of the aziyo cangaroo envelope were removed at that time.
 
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Brand NameCANGAROO ENVELOPE
Type of DeviceMESH, SURGICAL-FTM
Manufacturer (Section D)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer (Section G)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer Contact
michael hennick
1100 old ellis road
ste 1200
roswell, GA 30076
MDR Report Key12543720
MDR Text Key273686420
Report Number3005619880-2021-00030
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-XLG
Device Lot NumberM21D1130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1
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