Model Number 72912 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 03/28/2015 |
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 an upsylon y-mesh was implanted on (b)(6) 2015.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; groin pain; anal pain; rectal pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; aggravated incontinence; damage; psychiatric injury nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: betmiga for the treatment of: bladder urgency then a botox injection in 2019.Treatment duration: 4 years.On (b)(6) 2015 the patient commenced incontinence medication: aspalgin for the treatment of: treat migraines which became worse post surgery due to stress.Treatment duration: 6 years.On (b)(6) 2015 the patient commenced topical treatment (including oestrogen cream): vagifem low for the treatment of: treat atrophic vaginitis.Treatment duration: 6 years.
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Event Description
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It was reported to boston scientific corporation that an upsylon y-mesh was implanted on (b)(6) 2015.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; groin pain; anal pain; rectal pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; aggravated incontinence; damage; psychiatric injury nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: betmiga for the treatment of: bladder urgency then a botox injection in 2019.Treatment duration: 4 years.On (b)(6) 2015 the patient commenced incontinence medication: aspalgin for the treatment of: treat migraines which became worse post surgery due to stress.Treatment duration: 6 years.On (b)(6) 2015 the patient commenced topical treatment (including oestrogen cream): vagifem low for the treatment of: treat atrophic vaginitis.Treatment duration: 6 years.
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Manufacturer Narrative
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Block a1: meshc-20211002-51c03be8 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: 3005099803-2021-00053.
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Search Alerts/Recalls
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