Hospital affiliation: (b)(6) medical center.Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional product information was requested but, the complainant was unable to provide the model number, lot number or product sizing information.Additional information was requested from the complainant but, the complainant was unable to provide any further details related to the complaint issue.Therefore, we are unable to determine the specific manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.(b)(4).
|