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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, INC. CANGAROO FTM. SURGICAL MESH Back to Search Results
Model Number CMCV-009-MED
Device Problem No Apparent Adverse Event (3189)
Patient Problem Insufficient Information (4580)
Event Date 09/07/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, aziyo was notified by business partner boston scientific that a patient with a cardiovascular implantable electronic device (cied) system had a "pocket revision due to infection" on (b)(6) 2021. The revision included the explantation of the aziyo biologics cangaroo envelope (model cmcv-009-med, lot m21f1242, serial number (b)(4)). Based on the small amount of information obtained from boston scientific, it appears the implantation and explantation of this device was done on the same day. Multiple attempts were made to contact the physician for more details. The physician relayed a message that stated that the pocket revision was "not infection-related. " no further details are anticipated.
 
Manufacturer Narrative
No sample was returned for evaluation. Manufacturing review of the referenced lot number and respective device history record was conducted on 4oct2021, showing that all units were quality released on 13jul2021 having met all internal qc acceptance requirements. There were no non-conformances associated with the manufacturing lot during the final packaging. Sterile subassembly lot m21e1182 ((b)(4)) was also reviewed for potential issues impacting the quality of this product. This subassembly lot was released to component inventory on 21jun2021 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. The physician reported that this was a non-infection related event. It is unknown why there was a need for revision but it is unlikely it was due to the aziyo product.
 
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Brand NameCANGAROO
Type of DeviceFTM. SURGICAL MESH
Manufacturer (Section D)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
MDR Report Key12605044
MDR Text Key280815016
Report Number3005619880-2021-00033
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 distributor,health profession
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-MED
Device Lot NumberM21F1242
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/11/2021 Patient Sequence Number: 1
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