A review of the device lot history record indicated the device was manufactured to specifications.A total of 10 devices was produced from the lot.A review of the cbi complaint database did not reveal any additional complaints involving the reported lot number.Per the ifu, the device is supplied sterile to the end user.The device should be used "with caution in infection regions." infection is noted amongst the list of potential complications.The root cause, of the abscess and infection, is not likely device related.Such an occurrence could be procedure related and/or acquired post operatively.Cook biotech incorporated has a validated sterilization cycle with a sterility assurance level of (sal) 10^-6.The validated sterility cycle and all parameters of all devices are verified prior to release for distribution.
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