MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC CANGAROO ENVELOPE; MESH, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device model numbers and lot numbers are unknown.Manufacturing review of the device history record cannot be conducted.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication with the cangaroo envelope as stated in the ifu provided with the devices.It can be noted that the reporter indicated that all four (4) patients "cultured clean".If additional information is received for this event, a follow-up report will submitted.

Event Description

It was reported four (4) patients presented with infection like symptoms (pain, redness, swelling, fluid) post-op.Surgeon opened the patients to remove the devices and cultured the pockets.All 4 cultured clean; no infection.

• Brand Name: CANGAROO ENVELOPE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC; 1100 old ellis road; ste 1200; roswell, ga
• Manufacturer (Section G): AZIYO BIOLOGICS, INC; 1100 old ellis road; ste 1200; roswell, ga
• Manufacturer Contact: andrew green ; 1100 old ellis road; ste 1200; roswell, ga
• MDR Report Key: 9874272
• MDR Text Key: 191914129
• Report Number: 3005619880-2020-00029
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/24/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention