• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE 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 Hematoma (1884)
Event Date 10/12/2021
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 18-oct-2021, showing that all units were quality released on 18-aug-2021 having met all internal qc acceptance requirements. There were no non-conformances associated with the manufacturing lot during the final packaging. Sterile subassembly lot m21e1186 (prt-20679-03) was also reviewed for potential issues impacting the quality of this product. This subassembly lot was released to component inventory on 18-jun-2021 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. It is also noted that per the instructions for use (ifu - art-20828a) provided with the finished cangaroo envelope device, "hematoma" is listed as a potential complication associated with this procedure and device usage.
 
Event Description
Email from clinical research manager regarding a patient who had the removal of complete cardiovascular implantable electronic device (cied) system, including the aziyo cangaroo device on (b)(4) 2021. It was removed due to a left-sided pocket hematoma and a recent history of infection in previous right-sided pocket, without indication of infection of current site. On (b)(6) 2021, he went to the emergency department due to left pocket draining sanguineous drainage and slightly dehisced opening. He was placed on vancomycin/cefepime iv. Drainage changed from sanguineous to serous, no purulence. Patient was afebrile throughout hospital stay with one exception in emergency department of 100. 5 degrees fahrenheit. On (b)(6) 2021, device was explanted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12770641
MDR Text Key284834539
Report Number3005619880-2021-00042
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00859389005065
UDI-Public00859389005065
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-LRG
Device Lot NumberM21H1308
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2021
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: 11/08/2021 Patient Sequence Number: 1
Treatment
PACER CRT-P MRI MULTI-POINT RF-QUADRA ALLURE 3562
-
-