| Device Problem
Device Appears to Trigger Rejection (1524)
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| Patient Problems
Bacterial Infection (1735); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Necrosis (1971); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Myalgia (2238); Urinary Frequency (2275); Numbness (2415); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); Fibrosis (3167); No Information (3190); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for june-july 2014.This mdr is to reflect the additional information (event description, updated codes) to be added to the initial asr report.(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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Event Description
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This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for june-july 2014.This mdr is to reflect the additional information to be added to the initial asr report.As reported to coloplast though not verified, the patient was implanted with coloplast aris mesh on (b)(6) 2010.Later the patient experienced extrusion, infection, pain, urinary problems, vaginal scarring, dyspareunia, prolapse, bowel problems and incomplete bladder emptying.Urispas initiated for bladder spasms on (b)(6) 2010.The patient was implanted with coloplast exair mesh x 2 on (b)(6) 2010.Additional information indicated stress urinary incontinence prior to implant of exair.
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Event Description
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Additional information, as reported to coloplast though not verified, indicated: (b)(6) 2013-occasional bladder/bowel incontinence since aris/exair surgeries, fecal urgency, feels like prolapse has recurred, acute low back pain with intermittent right foot numbness, left sciatic pain, feels a knot on left back that is tender, lumbar spine x-ray - normal, lumbar spine ultrasound -normal, unable to do vaginal exam as claimant could not tolerate due to back pain.(b)(6) 2017 - increased dyspareunia, (+) bacterial vaginosis.(b)(6) 2017 - (b)(6) 2017: vaginal/bladder pressure, deep achiness in lower abdomen/vagina, intermittent sharp/shooting pain through vaginal canal, incomplete bladder emptying, urinary urgency/frequency/dysuria, fee urgency with occasional fecal incontinence, difficulty sleeping, dyspareunia that triggers bladder spasms, interstitial cystitis, fecal incontinence (b)(6) 2017 - (b)(6) 2017: recurrent uti's, continued dyspareunia.(b)(6) 2017 - unable to exercise due to chronic pelvic pain.(b)(6) 2020 - uti with hematuria.
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Manufacturer Narrative
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Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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Manufacturer Narrative
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H6 patient code 3191 - selected for nocturia.Vaginal bulge, "benign squamous mucosa"
patient code 3190: additional event information received that falls into this category = "urodynamics - altered sensation".Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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Event Description
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Additional information, reported to coloplast though not verified, indicated pain worse with sitting, bladder spasms, (b)(6)2013-(b)(6)2014.Urinary frequency 12-14x/day, nocturia 2-3x/night, occasional sui, 4 uti's/year with (+) e.Coli with constant dysuria even after treatment, fecal incontinence everyday since (b)(6) 2011, does not wear pads/carries a change of clothes with her at all times, back pain worsens incontinence and urgency, has felt vaginal bulge for 1.5 years when wiping/worse with straining, occasionally has to splint for bowel movement, exair/coloplast palpable anteriorly, tender to palpation, no erosion noted, scar around perineum, possible sphincter involvement, tender to palpation along vaginal cuff scar, mui, fecal incontinence/smearing, myalgia, scar pain, deep dyspareunia, urodynamics altered sensation.(b)(6) 2014: difficult partial removal of anterior exair/coloplast, anal sphincteroplasty, vaginal mucosa trimming, perineoplasty, cystoscopy.Intraoperative findings: exair/coloplast tightly banded along anterior vaginal wall with extensive fibrosis between exair/coloplast and the vaginal wall, interior and external anal sphincters with areas of fibrosis pathology: benign squamous mucosa, vaginal mucosa with mild chronic inflammation.(b)(6) 2014: approximate 1 cm area of wound breakdown with necrosis at anal sphincteroplasty site, in-office wound culture pathology showed (+) e.Coli.(b)(6) 2014: anal sphincteroplasty site unchanged.(b)(6) 2014: anal sphincteroplasty site still approximately 1 cm, now with fresh granulation tissue/healing, blue vicryl suture removed.(b)(6) 2014: anal sphincteroplasty site healing well, 1 mm area of peritoneum still needing to epithelialize.(b)(6) 2017: dyspareunia.(b)(6) 2017: claimant requesting gynecology referral for chronic dyspareunia/pelvic/perineal pain related to exair/coloplast, states urologist is not helping her.The exair for this patient was reported under 2125050-2020-00487.
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Manufacturer Narrative
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This follow-up mdr is created to document additional information received on record (b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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Event Description
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Additional information, reported to coloplast though not verified, 10/16/2017 - uti (+) staph coagulase.(b)(6) 2017 - acute cystitis (+) staph epidermidis (b)(6) 2018 - dyspareunia with entry/deep penetration, bilateral inguinal/groin pain, feels "tight", recurrent uti symptoms, urinary frequency, q30mins-1h, urinary urgency, nocturia, dysuria, interstitial cystitis.No aris or exair erosion/exposure noted, chronic pelvic pain, bladder pain.(b)(6) 2020 - ed visit - uti with hematuria.
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Search Alerts/Recalls
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