BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Discomfort (2330)
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Event Date 03/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2019, as the patient complained of discomfort in (b)(6) 2019 but no exact event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is implanted and 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 an uphold (tm) lite with capio slim device was implanted into the patient during a posterior repair procedure.The procedure was completed without complications.According to the complainant, in (b)(6) 2019, the patient postoperatively complained of discomfort.The patient felt like something was misplaced.An endoscopy procedure was performed and noticed some mesh in the rectum.Boston scientific has been unable to obtain additional information regarding the event and patient's current condition to date, despite good faith efforts.
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Search Alerts/Recalls
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