BOSTON SCIENTIFIC CORPORATION; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Disability (2371)
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Event Date 01/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that the mesh was implanted in 2015.However, the specific date is unknown and there was no reported adverse event onset date; therefore, date of event has been approximated to (b)(6) 2015.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 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 boston scientific mesh was implanted into the patient during a procedure in 2015 to treat pelvic organ prolapse.According to the patient, the mesh implant ruined her life.It has caused the patient the inability to continue working due to constant pain and she is now reliant on the disabilty support pension.Additionally, over the last few years, she is no longer be sexually active due to pain.Boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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