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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-XXL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)
Event Date 02/15/2022
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the cangaroo envelope device history record could not be performed as the lot/serial number is unknown. Although the exact cause of the reported infection cannot be conclusively determined, the current ifu delineates "infection" as a potential complication associated with the use of a cangaroo envelope and a surgical implant procedure.
 
Event Description
Email received from aziyo sales rep reporting explant due to infection. Patient described as 50-year old male with de novo s-icd implant in (b)(6) 2022 with explant one week later due to pus noted. Reported as "possibly related" to procedure and "possibly related" to aziyo device. Patient received medication and wearing a life vest, awaiting another implant. Dates in this report are approximate--actual dates unknown.
 
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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 Key14858264
MDR Text Key295063880
Report Number3005619880-2022-00016
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00859389005119
UDI-Public00859389005119
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-XXL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2022
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: 06/29/2022 Patient Sequence Number: 1
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