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
Hematoma (1884); Hemorrhage/Bleeding (1888)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The complainant indicated that the device was disposed 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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Event Description
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It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, at the end of the procedure, the patient had a lot of bleeding and there was a hematoma forming.It was flowing in the vagina so the right mesh arm was detached from the sacrospinous ligament.There was no way to re-implant this device so they had to discard the device.After they stopped the bleeding, they used "sloseal" to stop all the bleeding and then they implanted another uphold lite with capio slim device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Search Alerts/Recalls
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