BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number 850-211 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 06/21/2016 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an uphold prolapse mesh and an advantage fit incontinence sling were implanted into the patient on (b)(6) 2016.The patient experienced complications.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; anal pain; thigh pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury.Device 2 of 2 (advantage fit).
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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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Search Alerts/Recalls
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