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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 10/15/2021
Event Type  Injury  
Manufacturer Narrative
No samples were returned for investigation. Manufacturing review of the cangaroo envelope device history records for the reported event could not be completed as the lot/serial numbers were not provided. It is also noted that per the instructions for use (ifu-art-20828a) provided with the finished cangaroo envelope device, both "infection" and "hematoma" are listed as potential complications associated with this procedure and device usage. It is unknown if the device was explanted. Per the physician, no attempts were made to culture patient's wound for confirmation of infection. No other symptoms were mentioned for the event. Therefore, this event will be reported as a "hematoma" event. Should more information be received indicating the presence of infection, this report will be updated.
 
Event Description
An aziyo sales manager reported a conversation with a physician on (b)(6) 2021. The physician remarked that he had two (2) patients return "a couple of weeks ago" with "open pockets" following the implant of a pacemaker with an aziyo cangaroo envelope. The physician stated that the incisions were open but not the cangaroo pocket inside. The physician first indicated that the patients were infected. With further questioning, the physician said he had not cultured either patient and that it was possibly just a hematoma event in each case. He sent both patients to the electrophysiology lab for "lead extractions". Multiple attempts to obtain more information from the physician were unsuccessful. This report is regarding 'patient a'.
 
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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 Key12863128
MDR Text Key284710335
Report Number3005619880-2021-00045
Device Sequence Number1
Product Code FTM
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 Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/23/2021 Patient Sequence Number: 1
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