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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
Model Number CMCV-009-XLG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seroma (2069)
Event Date 08/12/2019
Event Type  Injury  
Manufacturer Narrative
A review of the complaint log shows that there are no other complaints associated with the parent lot number (m19d1150). Manufacturing review of the device history record for the reported lot shows that all units were quality released on 4/11/19 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 noted that the event is probably related to the procedure and possibly related to the device. It was also noted that the physician believes the event could be related to the inflammatory response. The exact relationship to the device cannot be conclusively determined. The instructions for use for the cangaroo envelope (art-20662b) under the section, potential complications, states in part, the following device-related complications are possible: allergic reaction to ecm, inflammation, seroma.
 
Event Description
It was reported that an (b)(6) year old male had a bi-v icd change out on (b)(6) 2019 (cangaroo envelope was soaked in a vancomycin solution for 2 minutes) and presented with puffiness in pocket at device check (approximately one week later). The puffiness did not subside, and the physician diagnosed the puffiness as a seroma. On (b)(6) 2019 the patient underwent seroma evacuation to drain the serous fluid. It is stated that the event was probably related to the procedure and possibly related to the device (envelope). Physicians believes this could be related to the inflammatory response. Patient is stable and pocket swab cultures were negative for any infection.
 
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Brand NameCANGAROO 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 Key8992586
MDR Text Key161956961
Report Number3005619880-2019-00010
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173242
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 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/07/2021
Device Model NumberCMCV-009-XLG
Device Lot NumberM19D1150035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2019
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: 09/11/2019 Patient Sequence Number: 1
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