Model Number 5196502400 |
Device Problems
Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Anemia (1706); Fatigue (1849); Foreign Body Reaction (1868); Incontinence (1928); Pain (1994); Scar Tissue (2060); Swelling (2091); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); No Information (3190); No Code Available (3191)
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Event Type
Injury
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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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Event Description
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As reported to coloplast though not verified, the patient's legal representative stated serious bodily injuries, including but not limited to, foreign body reaction, right lower quadrant pain, pelvic pain, dyspareunia, incontinence and other injuries.
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Manufacturer Narrative
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This follow-up mdr is created to document the additional patient dob, lot number, and explant date.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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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This follow up mdr is created to document the additional event information and correction/addition of h6 codes.Patient code 3191 was selected because the appropriate code was not available for "clotting", "pulling 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 post-operative bleeding and clotting, reinforcement of vaginal cuff and repair of left vaginal puncture under general anesthesia, pulling sensation on left side, low hemoglobin, pain and redness site, midurethral swelling with build-up of scar tissue at midline over the sling, urinary loss of control/incontinence, significant lower abdominal pain, worsened incontinence, dyspareunia, hematuria.(b)(6) 2018 - laparoscopy with lysis of adhesions, right salpingo-oophorectomy excision of altis suburethral sling, cystourethroscopy under general anesthesia.(b)(6) 2018 urine leakage with movement.
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Event Description
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Additional information received reported that, upon return to the operating room, a vaginal puncture site was discovered, which had occurred during the initial surgical attempt at altis placement.The patient experienced pain localized to point of fascial closure of left trocar site, fatigue, rolled mesh, and nocturia.Several periurethral bulking injections between 26jun2018 and 08jul2019.On (b)(6) 2019 cystourethroscopy and periurethral bulking injections took place.Intraoperative findings included urethrocele visible at the introitus, and bladder with mid trabeculations.
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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.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Search Alerts/Recalls
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