Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pubmed/1297571.(b)(4).The devices were not returned for review, therefore their conditions cannot be described.The device history record could not be reviewed as the item/lot numbers are unknown.The devices were used in treatment.No applicable patient history is available for review.Compatibility of the devices is unknown.A complaint history review could not be performed with the lack of identifying product information.With the information provided, a definitive root cause cannot be stated.
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