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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 Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 02/10/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 12/10/2020 having met all internal manufacturing specifications and qc acceptance requirements for workmanship. All sterilization processing records and bioburden testing indicated a successful sterilization cycle and passing results of product lal and sterility samples allowing the subassembly lot to be released for further packaging and labeling having met all criteria for release. There were no non-conformance's during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot. There were no deviations identified in this lot history record. 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. The instructions for use for the cangaroo envelope ((b)(4)) in use at the time of product shipment lists risk of hematoma and infection as potential complications. No additional details are available, should any additional information be obtained regarding this event, a follow-up report will be filed.
 
Event Description
It was reported on (b)(6) 2021 by aziyo business partner boston scientific that a cangaroo envelope (model cmcv-009-xlg, lot# m20n1387) was used in an icd replacement procedure on (b)(6) 2021 for a (b)(6) year-old male. Envelope was prepared by soaking in ancef/gentamicin/saline. Patient developed hematoma and pocket infection and went to (b)(6) hospital where the icd was explanted on (b)(6) 2021. It was reported that the cangaroo envelope was not removed. Patient was treated with antibiotics and doing well. New implant was performed two (2) days later in different site.
 
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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 Key11541480
MDR Text Key241813652
Report Number3005619880-2021-00003
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 health professional,other
Reporter Occupation
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-XLG
Device Lot NumberM20N1387
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 Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2020
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: 03/22/2021 Patient Sequence Number: 1
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