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

Model Number	CMCV-009-LRG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the distributed device manufacturing lot device history record for the reported event shows that all units were quality released to distribution on 01/24/2020 having met all internal qc acceptance requirements.Further review of subassembly lot shows that all sterilization cycle parameters, product bioburden, product lal and product sterility results met their respective acceptance criteria.There was one nonconformance associated with the subassembly manufacturing lot but investigation of nmr concluded no impact to the acceptability of this lot.In lieu of a request to the oem ecm supplier for dhr review, it is noted that aziyo biologics' processes utilize non-sterile materials which are further processed via cutting, suturing, packaging and sterilization.Further, as the exact cause of the reported event cannot be conclusively determined, should aziyo receive additional details from teh initial reporter, or our business partner, a supplemental report will be filed.
Event or Problem Description
It was reported that a patient implanted with an aziyo cangaroo envelope (model cmcv-009-lrg lot m20a1036) and a boston scientific defibrillator (model / lot # unknown), had his defibrillator device repaired on (b)(6) 2020 due to a discoloration of skin over [defibrillator] device header in pocket.There was a small dot of darkening skin over [defibrillator] header.Samples were sent to pathology.Aziyo cangaroo envelope remains implanted.This issue was reported to aziyo biologics by boston scientific on (b)(6) 2020.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL, FTM
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• MDR Report Key: 10177263
• Report Number: 3005619880-2020-00034
• Device Sequence Number: 16735858
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M20A1036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention