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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC CANGAROO ENVELOPE; MESH, SURGICAL

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AZIYO BIOLOGICS, INC CANGAROO ENVELOPE; MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Device model numbers and lot numbers are unknown.Manufacturing review of the device history record cannot be conducted.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication with the cangaroo envelope as stated in the ifu provided with the devices.It can be noted that the reporter indicated that all four (4) patients "cultured clean".If additional information is received for this event, a follow-up report will submitted.
 
Event Description
It was reported four (4) patients presented with infection like symptoms (pain, redness, swelling, fluid) post-op.Surgeon opened the patients to remove the devices and cultured the pockets.All 4 cultured clean; no infection.
 
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Brand Name
CANGAROO ENVELOPE
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
AZIYO BIOLOGICS, INC
1100 old ellis road
ste 1200
roswell, ga
Manufacturer (Section G)
AZIYO BIOLOGICS, INC
1100 old ellis road
ste 1200
roswell, ga
Manufacturer Contact
andrew green
1100 old ellis road
ste 1200
roswell, ga 
MDR Report Key9874272
MDR Text Key191914129
Report Number3005619880-2020-00029
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182255
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/25/2020
Initial Date FDA Received03/24/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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