BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502110 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Frequency (2275); Depression (2361); Weight Changes (2607); Dysuria (2684); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Fecal Incontinence (4571); Insufficient Information (4580)
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Event Date 10/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g3: other: tga device incident report reference no.87233; submitted to tga (therapeutic goods administration) by the patient.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf impact code f1202 captures the reportable event of unable to move.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a procedure performed on an unknown date.The patient reported pain with sex, coughing, sneezing, jumping, and emptying bowels and bladder as a result of the implant.She claimed to have bowel incontinence and wakes up multiple times per night to empty her bladder and sometimes her bowel too.Furthermore, the patient reportedly experienced loss of love life at the age of 29 as a result of device-related pain.She experienced mental anguish and depression; weight gain due to pain and inability to move; and associated issues due to weight gain.
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Search Alerts/Recalls
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