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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 Unspecified Infection (1930); Skin Erosion (2075)
Event Type  Injury  
Event Description
Email received from aziyo sales representative reporting that patient who underwent placement of a de novo icd (implantable cardioverter-defibrillator) with cangaroo envelope (model and lot unknown) developed a skin perforation with sanguineous drainage over the implant one month post-operatively (not at site of incision). Patient was given oral antibiotics which initially resolved the issue. Another skin perforation formed in a different location over the implant site and was again treated with oral antibiotics which appeared to resolve the issue. When a third perforation developed, the patient was hospitalized and given iv antibiotics which resolved the issue. There have been no further issues.
 
Manufacturer Narrative
No information was received providing the model or the lot number involved with this procedure. No product was returned to aziyo biologics for investigation. There were few details provided with this complaint and no dates were reported for any of these events. Since the use of antibiotics appeared to resolve the reported symptoms, it can be deduced that the source of the skin perforations was a pocket infection or cellulitis at the site of the implant, but not the actual incision. It is not possible to determine if the aziyo product was related to this event or if this was procedure-related, caused by trauma to the site, or due to an underlying patient condition. Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope device and a surgical implant procedure (instructions for use - (b)(4)). Should aziyo receive any additional details related to this event, a supplemental report will be filed.
 
Manufacturer Narrative
No information was received providing the model or the lot number involved with this procedure. No product was returned to aziyo biologics for investigation. There were few details provided with this complaint and no dates were reported for any of these events. Since the use of antibiotics appeared to resolve the reported symptoms, it can be deduced that the source of the skin perforations was a pocket infection or cellulitis at the site of the implant, but not the actual incision. It is not possible to determine if the aziyo product was related to this event or if this was procedure-related, caused by trauma to the site, or due to an underlying patient condition. Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope device and a surgical implant procedure (instructions for use - (b)(4)). Should aziyo receive any additional details related to this event, a supplemental report will be filed.
 
Event Description
Email received from aziyo sales representative reporting that patient who underwent placement of a de novo icd (implantable cardioverter-defibrillator) with cangaroo envelope (model and lot unknown) developed a skin perforation with sanguineous drainage over the implant one month post-operatively (not at site of incision). Patient was given oral antibiotics which initially resolved the issue. Another skin perforation formed in a different location over the implant site and was again treated with oral antibiotics which appeared to resolve the issue. When a third perforation developed, the patient was hospitalized and given iv antibiotics which resolved the issue. There have been no further issues.
 
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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 Key13523560
MDR Text Key285543368
Report Number3005619880-2022-00007
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 Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
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 Received01/21/2022
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: 02/14/2022 Patient Sequence Number: 1
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