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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 Unspecified Infection (1930)
Event Date 09/17/2020
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the cangaroo envelope device history record could not be completed as the lot/serial number for this event is not known. It is also noted that per the instructions for use (ifu - art-20662) provided with the finished cangaroo envelope device,infection is listed as a potential complication associated with the procedure and device. Although the exact cause of the reported infection cannot be conclusively determined, infection is 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
On 09/18/2020, it was reported by an aziyo sales representative that she had been informed of an infection involving cangaroo envelope (model #: unknown, lot #: unknown) at fort sanders regional hospital. Additional information was received on 10/09/2020 stating that patient returned for follow-up at 6 months post implant with an infection. Initial implant performed utilizing cangaroo envelope hydrated in vancomycin and gentamicin prior to implant (date not reported). Patient was referred to a larger hospital for extraction of the cied device and leads. It was also stated the event was not related to the aziyo device and probably related to the procedure as initial implant procedure lasted approximately 4 hours. Patient was healing and in stable condition.
 
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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
4705144023
MDR Report Key10680528
MDR Text Key211492360
Report Number3005619880-2020-00090
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,user faci
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2020
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: 10/14/2020 Patient Sequence Number: 1
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