The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device is implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an upsylon¿ was used during a laparoscopic sacrocolpopexy procedure performed on (b)(6) 2016.According to the complainant, after the procedure, the patient's prolapse returned.On mri it showed that the mesh got detached.The patient is scheduled for a surgery to patch the mesh together.Reportedly, there were no patient complications as a result of this event and the patient is fine.
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