Model Number 72912 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 09/21/2014 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2014 and advantage was implanted on (b)(6) 2014.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep; vaginal pain; pelvic pain; pain inter; inab inter; rec incont; nonsurgical treatments: on (b)(6) 2014 the patient commenced incontinence medication: incontinence pads for the treatment of: leakage of urine.Treatment duration: 7 years.
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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 into the patient on (b)(6) 2014 and an advantage sling was implanted on (b)(6) 2014.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; pelvic pain; painful intercourse; inability to have intercourse; recurrent incontinence nonsurgical treatments: on (b)(6) 2014 the patient commenced use of incontinence pads for the treatment of: leakage of urine.Treatment duration: 7 years.
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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 to h6 patient codes and below: a previous report for this patient and device has been sent under mfr report # 3005099803-2021-00015.
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Search Alerts/Recalls
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