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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 Problems Hematoma (1884); Seroma (2069)
Event Date 10/13/2021
Event Type  Injury  
Manufacturer Narrative
No sample was returned for evaluation. Manufacturing review of the cangaroo envelope device history record could not be performed as the model number and lot number are unknown. The report states that the patient had the evacuation of a hematoma on post-op day 1. This implies that the pocket was accessed for the removal of blood and the site healed without incident. This event was not reported to aziyo at the time. Swelling reappeared four months later and was thought to be a "seroma. " when the pocket was explored and the device explanted, it was reported that there was a large amount of "purulent discharge. " purulence usually indicates the presence of infection. However, cultures were reported as negative for growth, implying that there was not an active infection in the pocket. The "purulence" that was reported may have been the seroma fluid being evacuated or possibly some of the remodeled cangaroo envelope tissue which had been in place for four months. Since there was no confirmation of infection, the conclusion indicates that this was likely a "seroma" event. It is noted that per the instructions for use (ifu - (b)(4)) provided with the finished cangaroo envelope device, "hematoma" and "seroma" are listed as potential complications associated with this procedure and device usage. Should aziyo receive any additional details related to this event, a supplemental report will be filed.
 
Event Description
Report received from physician as follows: on (b)(6) 2021, patient had an icd (implantable cardioverter-defibrillator) generator change with implant of cangaroo envelope (no model or lot reported). On post-op day 1, she developed a hematoma which was evacuated. On (b)(6) 2021, patient presented with swelling of the icd pocket and underwent exploration with explant of the icd and the aziyo device. It was reported that there was a large amount of "purulent discharge. " icd with cangaroo envelope were implanted on contralateral side and patient has had no complications as a result of that procedure.
 
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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 Key13444248
MDR Text Key289265804
Report Number3005619880-2022-00005
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 Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
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 Received01/13/2022
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: 02/03/2022 Patient Sequence Number: 1
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