• 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-XLG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 09/18/2020
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the cangaroo envelope device history record for the reported lot shows that all packaged and labeled units were quality released to distribution on 07/23/2020 having met all internal qc acceptance requirements. All sterilization processing records and bioburden testing indicate 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. Any non-conformances during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot were successfully resolved prior to lot release and not associated with the reported event. 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 (ifu - art-20662) provided with the finished cangaroo envelope device, hematoma is listed as a potential complication associated with the procedure and device. Although the exact cause of the reported hematoma cannot be conclusively determined, hematomas are a known complication associated with the use of a cangaroo envelope and a surgical implant procedure. 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-xlg, lot# m20g1218) was implanted (date unknown) with a boston scientific crt-d (model# / serial # - unknown). The patient underwent a hematoma evacuation procedure on (b)(6) 2020 and ultimately a device extraction on (b)(6) 2020. No further information is available at the time of this filing. Should any additional details be received by aziyo, a supplemental report will be filed.
 
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 Key10954218
MDR Text Key219963141
Report Number3005619880-2020-00097
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 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-XLG
Device Lot NumberM20G1218
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 Received11/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2020
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: 12/05/2020 Patient Sequence Number: 1
-
-