BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-708 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 11/09/2010 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an uphold was implanted on (b)(6) 2010 and an advantage was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: pelvic pain; pain inter; inab inter; rec incont; aggrav incont; damage; psych.Nonsurgical treatments: the patient was treated with pain medication: lyrica for the treatment of: pain.Treatment duration: 4 years.The patient was treated with psychological medication: tamaze.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: physiotherapy.The patient was treated with injections (not associated with surgical treatment): nerve for the treatment of: nerve pain.Treatment duration: 2 or 3 times.The patient was treated with other (please specify) for the treatment of: mediation/psychologists to try and settle nerve 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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Event Description
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It was reported to boston scientific corporation that an uphold was implanted on (b)(6)2010 and an advantage was implanted on (b)(6)2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: pelvic pain; pain inter; inab inter; rec incont; aggrav incont; damage; psych nonsurgical treatments: the patient was treated with pain medication: lyrica for the treatment of: pain.Treatment duration: 4 years.The patient was treated with psychological medication: tamaze.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: physiotherapy.The patient was treated with injections (not associated with surgical treatment): nerve for the treatment of: nerve pain.Treatment duration: 2 or 3 times.The patient was treated with other (please specify) for the treatment of: mediation/psychologists to try and settle nerve pain.
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Manufacturer Narrative
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Block a1: meshc-20210927-e801c101.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 # 3005099803-2020-06622.
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