Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device was not to 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 y-mesh device was implanted into the patient during a procedure performed on an unknown date.The patient was sent home after the implant with various medications for recovery.However, in later days these medications were discontinued as the patient presented with allergic reaction and itching.Videos provided showed skin rashes on the patient's arms and legs.The device remained implanted.The patient had treatment for allergy; however, the issue has not been resolved.
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