Manufacturing review of the cangaroo envelope device history record for the reported lot shows that all packaged and labeled units were quality released to distribution on 10sep2020 having met all internal qc acceptance requirements.All sterilization processing records and bioburden testing indicate a successful sterilization cycle and passing results of product lal and sterility samples allowing the subassembly lot to be released for further packaging and labeling having met all criteria for release.There were no non-conformances during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging and sterilizing the product.It is also noted that per the instructions for use (ifu - art-20662) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported infection cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope and a surgical implant procedure.No further details were available for this event, should aziyo receive any additional details related to this event, a supplemental report will be filed.
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It was reported on 01mar2021 by aziyo sales representative that the patient's icd generator was changed out on (b)(6) 2021 using a cangaroo envelope (model #: cmcv-009-xlg; lot #: m20k1262) having been soaked in saline for 1 - 2 minutes.On (b)(6) 2021, doctor reported that patient had yellow pus draining from implant site.Patient was hospitalized for 3 days for iv antibiotics and then discharged home on oral antibiotics for 7days.Infection has now resolved and patient is in good health.Pacemaker and cangaroo envelope remain implanted.No further details are available for this event, should additional information be received related to this event, a supplemental report will be filed.
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