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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL

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AZIYO BIOLOGICS, INC. CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL Back to Search Results
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Host-Tissue Reaction (1297); Hematoma (1884); Seroma (2069)
Event Date 12/06/2018
Event Type  Injury  
Manufacturer Narrative
According to instruction for use (art-20524b 09/2016) under potential complications, it states: allergic reaction to ecm, hematoma and seroma. Under the section labeled "contraindications: the cormatrix cangaroo ecm envelope is derived from a porcine source and should not be used in patients with a known sensitivity to porcine material. " under the section warnings and precautions, it states in part, "do not use the cormatrix cangaroo with fibrin glue or glue containing glutaraldehyde or other cross-linking agents. " under the section suggested instructions for implanting the cormatrix cangaroo ecm envelope it states in part, "hydrate the cormatrix cangaroo ecm envelope by completely immersing it in a bowl of sterile water, sterile saline or sterile lactated ringers solution for 1-2 minutes prior to use. " the ifu for cangaroo states in part, ""do not use the cormatrix cangaroo with fibrin glue or glue containing glutaraldehyde or other cross-linking agents. " it can be noted that the pocket was flushed with an "antibiotic solution", however the medical records do not indicate what antibiotic solution was used. According to the medical records the patient is allergic to amoxicillin. Although the exact cause of the reported event cannot be conclusively determined, seroma, hematoma and allergic reaction are known potential complications with the cangaroo ecm. It can also be noted that the cangaroo ecm should not be used with any other cross-linking agents.
 
Event Description
It was reported that on (b)(6) 2018, a (b)(6) year-old male patient ((b)(6), white/not hispanic or latino) had an implant of a cangaroo product (size medium, lot unknown). Approximately 10 days later the patient developed a seroma which was stated by implanting physician to be a "normal reaction to surgery" and to wait for swelling to go down (event observed in united states). Approximately 7 weeks later, the wound had not healed and burst. Cultures were taken and it was reported that "normal body flora was present, no bacteria" (observed in (b)(6)). The patient went to a different doctor on (b)(6) 2018 for consult (completed in (b)(6)). On (b)(6) 2018 the ecm device was removed and a hematoma behind the pocket as well as a foreign body reaction was observed (observed in (b)(6)). Additional information has been requested.
 
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Brand NameCORMATRIX CANGAROO ECM 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 Key8258972
MDR Text Key133478164
Report Number3005619880-2019-00001
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K140306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2018
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: 01/17/2019 Patient Sequence Number: 1
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