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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 Hematoma (1884)
Event Date 10/08/2021
Event Type  Injury  
Manufacturer Narrative
No sample was returned for evaluation. Manufacturing review of the cangaroo device history record could not be performed as the model/lot/serial numbers were not reported. It is also noted that per the instructions for use (ifu - art-20828a) provided with the finished cangaroo envelope device, 'hematoma' is listed as a potential complication associated with this procedure and device usage. The patient was on anticoagulants which would have increased the likelihood of post-operative hematoma formation. The ifu provided with the aziyo product indicates that the usage of certain glues in contact with the device can interrupt the remodeling process. However, the reference to the use of glue to seal the incision likely had no impact on the reported hematoma formation. The presence of the hematoma likely led to the wound dehiscence as there would have been pressure exerted on the incision, allowing for the failure of the glue. Therefore, the wound opening was not a separate adverse event related to the aziyo product itself but likely caused by the adverse event of the hematoma.
 
Event Description
Clindex report from site stated adverse event during (b)(6) study indicating that patient was implanted with a cangaroo envelope on (b)(6) 2021 (model # / lot # not reported) hydrated with saline and gentamicin and a st. Jude pacemaker (quadra allure mp 3562). Patient was given iv antibiotics (cefazolin) intra-op. No hemostatic agents were given intra-pocket during the implant. Pocket incision was closed with glue (type not specified). On (b)(6) 2021, patient presented at follow-up visit with a hematoma and procedure/visit notes state that there was a 1. 5cm opening in the wound noted. Surgical site was repaired with 3 silk sutures and prophylactic oral antibiotics (keflex for 7 days) prescribed. Event resolved without sequelae. Hematoma event listed as "mild" and "probably-related" to procedure and "possibly" related to aziyo device.
 
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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 Key12811001
MDR Text Key282357991
Report Number3005619880-2021-00044
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 Study,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
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 Received10/22/2021
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: 11/15/2021 Patient Sequence Number: 1
Treatment
QUADRA ALLURE MP 3562 (ST. JUDE)
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