BOSTON SCIENTIFIC CORPORATION PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317170 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/08/2013 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2013 as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6) phone number: (b)(6).Fax number: (b)(6).(b)(4).The complaint device is not expected 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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Event Description
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It was reported to boston scientific corporation that a pfr kit uphold lite vaginal support system was implanted during an uphold posterior, sacrospinous fixation (ssf) with urethral dilation and cystoscopy with hydrodistention procedure performed on (b)(6) 2013 to treat pelvic organ prolapse.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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