Model Number 72912 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 11/19/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 upsylon y-mesh implant was implanted into the patient on (b)(6) 2014.The patient experienced complications and further surgery.Patient symptoms include: eep; vaginal pain; pain inter; inab inter; off vag dis; diff bowel; surgical interventions: on (b)(6) 2014 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: revision for mesh exposure.
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Event Description
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It was reported to boston scientific corporation that a upsylon y-mesh implant was implanted into the patient on (b)(6) 2014.The patient experienced complications and further surgery.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions surgical interventions: on (b)(6) 2014 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: revision for mesh exposure.
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Manufacturer Narrative
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Block a1: meshc-20211028-e93a7b49.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.Block h10: the complainant indicated that the device is not available for return; 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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Search Alerts/Recalls
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