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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, INC. CANGAROO MESH, SURGICAL-FTM Back to Search Results
Model Number CMCV-009-LRG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/07/2021
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 14sep2021, showing that all units were quality released on 07oct2019 having met all internal qc acceptance requirements. There were no nonconformances associated with the manufacturing lot during the final packaging. Sterile subassembly lot m19h1356 (prt-20679-03) was also reviewed for potential issues impacting the quality of this product. This subassembly lot was released to component inventory on 09sep2019 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 nonsterile 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, infection is listed as a potential complication associated with this procedure and device usage.
 
Event Description
On (b)(6) 2021, aziyo was notified by business partner boston scientific that a patient with a biventricular pacemaker (biv) implanted on (b)(6) 2021 and aziyo biologics cangaroo envelope (model cmcv-009-lrg, lot number m19l1435) presented with pocket infection. The aziyo device was explanted as part of the removal of the entire cardiovascular implantable electronic device (cied) system on (b)(6) 2021. Patient was treated with iv antibiotics and had a new device with aziyo envelope reimplanted on (b)(6) 2021. Patient is reportedly doing well.
 
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Brand NameCANGAROO
Type of DeviceMESH, SURGICAL-FTM
Manufacturer (Section D)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
MDR Report Key12568418
MDR Text Key281087855
Report Number3005619880-2021-00032
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K201313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-LRG
Device Lot NumberM19L1435
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
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