TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿; MESH, SURGICAL, POLYMERIC
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Model Number IVS02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Pain (1994); Pneumonia (2011); Sepsis (2067); Septic Shock (2068); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Burning Sensation (2146); Peritonitis (2252); Urinary Frequency (2275); Diaphoresis (2452); Confusion/ Disorientation (2553); Hematuria (2558); Ascites (2596); Dysuria (2684); Constipation (3274); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Death
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vaginal reconstruction.It was reported that after implant, the patient experienced urinary tract infection, vulval lichen sclerosis, sepsis, difficulties with bowel motions, diverticulitis, urinary incontinence, urinary retention, peritonitis, hypotension, pain, infection, impairment of household chores/entertainment/physical activities, emotional changes, blood in urine, leukocytes, gram positive cocci resembling staphylococcus epidermis, klebsiella oxytoca, pseudomonas auruginosa, dysuria, nausea, vomiting, pyuria (burning urination), urinary frequency, gastroparesis, sweats, confusion, delirium, rapid decline in strength, lobar pneumonia, septic shock, urosepsis with thick purulent urine, right sided pneumonia, hypotension, hyperkalemia, hyponatremia, abdominal pain, ileus, edema, bilateral nephrosis, chronic liver disease, free intraperitoneal fluid, acute kidney injury, and death.Post-operative patient treatment included hospitalization, metaraminol infusion, dobutamine, noradrenaline infusions, and medication.Information received indicates the patient is now deceased, due to multi-organ failure from urinary system and respiratory sepsis, chronic myeloproliferative disorder and diabetes.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vaginal reconstruction.It was reported that after implant, the patient experienced death, urinary tract infection, vulval lichen sclerosis, sepsis, difficulties with bowel motions, diverticulitis, urinary incontinence, urinary retention, peritonitis, hypotension, pain, infection, impairment of household chores/entertainment/physical activities, emotional changes, blood in urine, leukocytes, gram positive cocci resembling staphylococcus epidermis, klebsiella oxytoca, pseudomonas auruginosa, dysuria, nausea, vomiting, pyuria (burning urination), urinary frequency, gastroparesis, sweats, confusion, delirium, rapid decline in strength, lobar pneumonia, septic shock, urosepsis with thick purulent urine, right sided pneumonia, hypotension, hyperkalemia, hyponatremia, abdominal pain, ileus, edema, bilateral nephrosis, chronic liver disease, free intraperitoneal fluid, and acute kidney injury.Post-operative patient treatment included hospitalization, metaraminol infusion, dobutamine, noradrenaline infusions, and medication.Information received indicates the patient is now deceased, due to multi-organ failure from urinary system and respiratory sepsis, chronic myeloproliferative disorder and poorly controlled diabetes.
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Search Alerts/Recalls
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