Model Number UR31051002 |
Device Problems
Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Neuropathy (1983); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Ambulation Difficulties (2544); Dysuria (2684); Constipation (3274); Suicidal Ideation (4429); Dyspareunia (4505); Sexual Dysfunction (4510)
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Event Date 09/20/2022 |
Event Type
Injury
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Event Description
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According to available information, this device required an emergency room visit due to pain.The patient felt intense pain in her vagina while sitting at workstation and was taken to the emergency room.She reports she is not able to work due to pain while sitting, not able to drive due to pain, has chronic pain with walking, burning in vagina, dyspareunia, takes neuropathic medication twice daily, and takes anti-depressants.She has two follow up appointments, one at the pain center and another for pelvic infiltration.
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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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Manufacturer Narrative
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A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.The restorelle device referenced in b5 is captured under a separate manufacturing report number.
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Event Description
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The patient had two types pf prosthesis [restorelle and aris].Additional information was provided to coloplast, though not verified: immediately post restorelle and aris placement, the patient had favorable postoperative follow-up.Since the implant, the patient reportedly has also experienced abdominal and pelvic pain during sexual intercourse, difficulties with walking (moving in a wheelchair) and prolonged sitting; constipation; recurrent urinary tract infections; suicidal ideation; vagal discomfort and dysuria.The patient also reported that the slings were too tight (left side) causing the pain.An ultrasound of the aris reported asymmetrical positioning in an axial plane with a tight appearance on the left.Urethral erosion could not be formally eliminated.An explant procedure was performed on (b)(6) 2023.
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Search Alerts/Recalls
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