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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 Wound Dehiscence (1154); Unspecified Infection (1930)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the cangaroo envelope device history record for the reported lot reflects that all packaged and labeled units were quality released to distribution on 2/12/2020 having met all internal qc acceptance requirements. All sterilization processing records and bioburden testing results indicate a successful sterilization cycle, and passing results of lal and sterility bis allowed the subassembly lot to be released for further packaging and labeling activities. There were no non-conformances during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot. 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. It is also noted that per the instructions for use (art-20662) provided with the packaged cangaroo envelope device, that infection is listed as a potential complication associated with the surgical procedure and usage of the cangaroo envelope. Although the exact cause of the reported infection cannot be conclusively determined, infection is a known complication associated with the surgical implantation of the cied and the cangaroo envelope devices. Should aziyo receive any additional details related to this event, a supplemental report will be filed.
 
Event Description
It was reported by aziyo biologics' business partner boston scientific, that a cangaroo envelope (model cmcv-009-med lot# m20b1068) was used with a boston scientific pacemaker (model #/serial # unknown) and implanted on (b)(6) 2020. It was reported that the patient was admitted on (b)(6) 2020 due to infected pacemaker with wound dehiscence. The entire system, including the aziyo cangaroo envelope were explanted on 7/1/2020. Wound was irrigated with antibiotic solution after explanting the device. The issue was reported to aziyo biologics on 8/18/2020.
 
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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
4705144023
MDR Report Key10541396
MDR Text Key207196611
Report Number3005619880-2020-00045
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,use
Reporter Occupation
Type of Report Initial
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/06/2022
Device Model NumberCMCV-009-MED
Device Lot NumberM20B1068
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 Received08/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2020
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: 09/16/2020 Patient Sequence Number: 1
Treatment
BSC PACEMAKER (MODEL#/SERIAL# - UNKNOWN)
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