Model Number 5196502400 |
Device Problems
Patient-Device Incompatibility (2682); Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Scarring (2061); Swelling (2091); Tissue Damage (2104); Abnormal Vaginal Discharge (2123); Anxiety (2328); Discomfort (2330); Injury (2348); Prolapse (2475); Abdominal Cramps (2543); Blood Loss (2597); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Event Description
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According to the available information, patient's legal representative stated foreign body reaction, dyspareunia with bleeding, abdominal cramping, lower back pain, anxiety, and other injuries.
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Manufacturer Narrative
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This follow-up was created to document the additional device and patient information.The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.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.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 explant date.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 the mesh was removed.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information reported to coloplast though not verified, swelling/discomfort, mild urinary urgency, pelvic cramping, pelvic pressure, mild bulging, pelvic/vaginal pain.(b)(6) 2017 - partial excision of altis, cystocele repair with soft tissue excision, vaginal mucosa tripping, cystoscopy - slight adhesion to periurethral tissue, small rectocele, scarring, foreign body reaction, benign vaginal squamous epithelium.(b)(6) 2017 - surgical site soreness, vaginal discharge (b)(6) 2017 - dyspareunia, post-coital spotting, atrophic vaginitis.(b)(6 2017 - (b)(6) 2017 - llq pain radiating to low back/neck with daily headaches since coloplast implant/removal surgeries.(b)(6) 2017 - mri pelvis -granulation tissue from vaginal cuff along posterior bladder.
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Search Alerts/Recalls
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