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Model Number TEM1515G |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Erythema (1840); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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 a recurrent ventral hernia.It was reported that after implant, the patient experienced pain, abscesses, non-healing open draining wound, fever, seroma, hernia recurrence, scarring, adhesions, persistent infections, loss of consortium, and episodes of erythema.Post-operative patient treatment included multiple additional surgeries.
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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 a recurrent ventral hernia.It was reported that after implant, the patient experienced defective device, mental pain, permanent impairment, loss of enjoyment of life, indurated tissue, scar tissue, fluid buildup, inflammation, mesh failure, pain, abscesses, non-healing open draining wound, fever, seroma, hernia recurrence, scarring, adhesions, persistent infection, and episodes of erythema.Post-operative patient treatment included multiple additional surgeries, debridement procedures, hernia repair with mesh, and removal of mesh.
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Manufacturer Narrative
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Additional info: b2, b5, d1, d4 (model #, catalog #), d6b, d8, e1 (facility name, street 1, city, region, postal code), g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, country code, postal code, email, phone number), g3, g4 (pma/510k), h6 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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Manufacturer Narrative
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Additional info: d4 (expiration date, lot #, unique identifier (udi) #), g1, h4 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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