The complainant declined to provide the injured individual contact information or product information to steris.Steris instructed the complainant to have the user follow the safety data sheet (sds) for the product.Due to the complainants refusal to provide contact or product information, steris is unable to obtain additional details; specifically, if the user sought or received medical treatment.We have been unable to obtain additional information regarding the reported event and therefore filing this report as we cannot determine if the event meets the reporting criteria outlined in 21 cfr 803.A follow-up report will be filed should we receive additional information.
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