BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-817 |
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 12/28/2017 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a uphold lite implant was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; pelvic 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 under general anesthesia for the following purpose: ongoing pelvic pain.On (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: ongoing vaginal pain.
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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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Manufacturer Narrative
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Block a1: (b)(4) 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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2021-00024.
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Event Description
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It was reported to boston scientific corporation that a uphold lite implant was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; pelvic 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 under general anesthesia for the following purpose: ongoing pelvic pain.On (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: ongoing vaginal pain.
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Search Alerts/Recalls
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