Model Number 72912 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Depression (2361); Constipation (3274); Dyspareunia (4505)
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Event Date 06/18/2019 |
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 an upsylon y-mesh was implanted on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: pelvic pain; pain inter; diff bowel.Nonsurgical treatments: on (b)(6) 2019 the patient commenced psychological medication: escitalopram sandoz for the treatment of: depression.Treatment duration: 2 years 3 months.The patient was treated with other medication (please specify).
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Event Description
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It was reported to boston scientific corporation that an upsylon y-mesh was implanted on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: pelvic pain; painful intercourse; difficulties with bowel motions.Nonsurgical treatments: on (b)(6) 2019 the patient commenced psychological medication: escitalopram sandoz for the treatment of: depression.Treatment duration: 2 years 3 months.The patient was treated with other medication (not specified).
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Manufacturer Narrative
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Block a1: (b)(6).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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