BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number 850-700 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 01/01/2018 |
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 solyx implant was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; oth pain; pain inter; inab inter; off vag dis; diff bowel; rec incont; aggrav incont; damage; psych; surgical interventions: on (b)(6) 2019 the patient underwent further surgery for the following purpose: severe inflammation/infection of right breast.
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Manufacturer Narrative
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Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06755.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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Event Description
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It was reported to boston scientific corporation that a solyx implant was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; oth pain; pain inter; inab inter; off vag dis; diff bowel; rec incont; aggrav incont; damage; psych; surgical interventions: on (b)(6) 2019 the patient underwent further surgery for the following purpose: severe inflammation/infection of right breast.
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