BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505)
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Event Date 03/08/2012 |
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 uphold was implanted on (b)(6) 2012.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; other pain: stomach pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence surgical interventions: on (b)(6) 2015 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: constant pain and ongoing vaginal/bladder infections.On (b)(6) 2020 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: constant pain and ongoing vaginal/bladder infections.Nonsurgical treatments: on (b)(6) 2012 the patient commenced pain medication: panadeine forte, for purpose: relieve pain.Treatment duration: 9 years.On (b)(6) 2012 the patient commenced psychological medication: lovan for purpose: anti depressant.Treatment duration: 9 years.On (b)(6) 2012 the patient commenced pain medication: mobic for purpose: anti-inflammatory for constant pain.Treatment duration: 9 years.
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Event Description
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It was reported to boston scientific corporation that an uphold vaginal support system was implanted into the patient during vaginal hysterectomy, monarc sling, anterior repair with mesh, bilateral sacrospinous fixation procedure performed on (b)(6) 2012, for the treatment of cystocele, menorrhagia and urinary incontinence.Following the procedure, the patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; other pain: stomach pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence.Surgical interventions: on (b)(6) 2015, the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: constant pain and ongoing vaginal/bladder infections.On (b)(6) 2020 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: constant pain and ongoing vaginal/bladder infections.Nonsurgical treatments: on (b)(6) 2012 the patient commenced pain medication: panadeine forte, for purpose: relieve pain.Treatment duration: 9 years.On (b)(6) 2012 the patient commenced psychological medication: lovan for purpose: anti depressant.Treatment duration: 9 years.On (b)(6) 2012 the patient commenced pain medication: mobic for purpose: anti-inflammatory for constant pain.Treatment duration: 9 years.
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Manufacturer Narrative
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Block a1: (b)(6).Correction: block b3 date of event has been corrected.Block b3 date of event: date of event was approximated to (b)(6) 2012, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr (b)(6).(b)(6).Block h6: patient code e2330, e1405, e1401, e1906 capture the reportable events of pain, dyspareunia, abnormal vaginal discharge, infection.Impact code f19, f2303, f12 capture the reportable events of surgical intervention, medication required, and legal claim filed for the personal injuries related to the device.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is not available for return; therefore, a device 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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