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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-MED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Sepsis (2067)
Event Date 05/07/2021
Event Type  Injury  
Manufacturer Narrative
No sample was returned for investigation. Manufacturing review of the referenced lot number and respective device history record was conducted on 19may2021, showing that all units were quality released on 21july2020 having met all internal qc acceptance requirements. There were no non-conformances associated with the manufacturing lot during the final packaging. Sterile subassembly lot m20c1119 was also reviewed for potential issues impacting the quality of this product. This subassembly lot was released to component inventory on 22apr2020 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 dhr review, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging and sterilizing the product. A review of the instructions for use (ifu-art-20662c) provided with the finished cangaroo envelope device states under the section potential complications: the following device-related complication is possible: infection. Although distributor reported this as an "infection with sepsis," it is known that the distributor is unable to differentiate between pocket infection and sepsis in their reporting. In the absence of further details from the physician, it is not possible to determine if this was a pocket infection or actually sepsis. The device was explanted and the patient was put on iv antibiotics. Should aziyo receive any additional information related to this event, a follow-up report will be submitted.
 
Event Description
It was reported by aziyo's business partner, boston scientific, that a cangaroo envelope (model #: cmcv-009-med / lot #: m20g1215) was explanted on (b)(6) 2021 due to infection. Additional information received from business partner reported that this was an "infection with sepsis" and the patient was placed on iv antibiotics. The initial implant of the cangaroo envelope and pacemaker was performed on (b)(6) 2021. Multiple attempts were made to confirm sepsis report and to get additional information from implanting physician, but were unsuccessful. Should aziyo receive any additional information regarding the reported event, an update report will be submitted.
 
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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 Key11987144
MDR Text Key255809199
Report Number3005619880-2021-00020
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-MED
Device Lot NumberM20G1215
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 Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2020
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: 06/11/2021 Patient Sequence Number: 1
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