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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL

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AZIYO BIOLOGICS, INC. CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL 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 07/25/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 9/27/2016 having met all internal qc acceptance requirements. All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release. There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging. The site investigator noted that the event is possibly related to the procedure and possibly related to the device. The probable cause is listed as, "procedure". However the exact relationship to the device cannot be conclusively determined as the device was not returned for evaluation. The instructions for use (lb-20266 provided with device) for the cangaroo ecm envelope currently lists hematoma as potential complications associated with the procedure and device.
 
Event Description
The subject is a (b)(6) year old male who had an initial procedure of icd replaced with a cardiac resynchronization therapy defibrillator (crt-d) on (b)(6) 2017 where the ecm (cmcv-009-xlg, lot # m16h1214) was hydrated in normal saline (unknown length of time). At the subjects incision check on (b)(6) 2017, a moderate hematoma was noted at the incision site. At the 4-6 week visit on (b)(6) 2017 the hematoma was resolved. This required no intervention. The site investigator states that the event is possibly related to the procedure and possibly related to the device. The probable cause is listed as "procedure".
 
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Brand NameCORMATRIX CANGAROO ECM ENVELOPE
Type of DeviceMESH, SURGICAL
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
andrew green
1100 old ellis road
ste 1200
roswell, GA 30076
MDR Report Key6937268
MDR Text Key89149622
Report Number3005619880-2017-00029
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00859389005072
UDI-Public00859389005072
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/24/2019
Device Model NumberCMCV-009-XLG
Device Lot NumberM16H1214
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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