|
Model Number UNK SURGIPRO MESH |
Device Problems
Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Abdominal Pain (1685); Erosion (1750); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Micturition Urgency (1871); Granuloma (1876); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Numbness (2415); Prolapse (2475); Abdominal Distention (2601); Dysuria (2684); Constipation (3274); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
Difficulty defecating.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.
|
|
Event Description
|
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment.It was reported that after implant, the patient experienced infection, vaginal pain, cystocele, urgency, incontinence, pain, difficulty defecating, urinary frequency, nocturia, urinary tract infection, vaginal laxity, dyspareunia, abdominal pain, constipation, overactive bladder, emotional changes.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment.It was reported that after implant, the patient experienced infection, vaginal pain, emotional changes, urinary frequency, micturation urgency, incontinence, urinary tract infection,dysuria, fever, abdominal pain, overactive bladder symptoms, pain, reduced sensation around the vagina, vaginal laxity, vaginal dryness, soreness, cystocele, prolapse, difficulty defecating, constipation, scarring, vaginal/vulvar atrophy, discomfort, bleeding/spotting, nausea, vomiting, urinary retention, tenderness, mesh erosion, mesh exposure, granuloma, nocturia, burning pain, pelvic floor weakness, pus, vaginal discharge, mesh protrusion, extrusion of mesh, bloating, nodule at perineum, and dyspareunia.Post-operative patient treatment included medication, catheter placed, removal of mesh, admission to hospital, vaginal overlay closure, a pds stitch removed from top of incision, posterior repair, and cystocele repair with additional mesh.
|
|
Manufacturer Narrative
|
Additional information: a3, a4, b2, b5, b6, b7, h6 (added patient, device, and imf codes) ime 2402: difficulty defecating, vaginal dryness, nodule 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.
|
|
Search Alerts/Recalls
|
|
|