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Model Number 20204 |
Device Problem
Defective Device (2588)
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Patient Problems
Injury (2348); Disability (2371)
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Event Date 05/04/2015 |
Event Type
Injury
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Manufacturer Narrative
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At the time of this investigation, no samples or lot numbers were provided to cardinal health.Therefore; without a lot number we were not able to review the device history record and without a sample we were not able to perform any type of investigation in order to determine a root cause for the issue reported.At this time, no corrective actions will be initiated for this complaint.The manufacturing facility will continue to monitor for any similar complaints and take action if determined.
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Event Description
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According to the litigation received.Plaintiff claims by reason of the defective product, the plaintiff was caused to sustain severe and permanent personal injuries and disability.
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Manufacturer Narrative
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On october 3, 2018 cardinal health received pictures of catalog number 20204 as well as the lot number v0k045.The device history record review was completed on the reported lot v0k045.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Pictures of the ice pack were evaluated.After review of the pictures, we were unable to determine a root cause, as no anomalies were observed.Without a sample we were not able to perform any type of investigation in order to determine a root cause for the issue reported.At this time, no corrective actions will be initiated for this complaint.The manufacturing facility will continue to monitor for any similar complaints and take action if determined.
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Search Alerts/Recalls
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