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); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 07/22/2009 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (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 upsylon y-mesh implant and a advantage implant were implanted into the patient on (b)(6) 2009.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; pain inter; inab inter; diff bowel; rec incont.Surgical interventions: on (b)(6) 2009 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: surgery on (b)(6) 2009 was to remove the mesh which had dislodged and this surgery (b)(6) 2009 was to put a new one in.Nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: paracetamol for the treatment of: to relieve discomfort.Treatment duration: ongoing.The patient was treated with topical treatment (including oestrogen cream): vagifem for the treatment of: to thicken the vaginal walls and to assist with the painful intercourse.Treatment duration: ongoing.
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Manufacturer Narrative
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Correction: b5, h6 patient, impact codes.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 h6: evaluation 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 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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Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the upsylon y-mesh.It was reported to boston scientific corporation that an upsylon y-mesh and an advantage sling were implanted into the patient on (b)(6) 2009.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence.Surgical interventions: on (b)(6) 2009 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: surgery on (b)(6) 2009 was to remove the mesh which had dislodged and this surgery (b)(6) 2009 was to put a new one in.Nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: paracetamol for purpose: to relieve discomfort.Treatment duration: ongoing.The patient was treated with topical treatment (including oestrogen cream): vagifem for purpose: to thicken the vaginal walls and to assist with the painful intercourse.Treatment duration: ongoing.
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Search Alerts/Recalls
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