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Model Number TECR1515 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Cellulitis (1768); Edema (1820); Hematoma (1884); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Scarring (2061); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191); 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
Injury
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Manufacturer Narrative
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Concomitant medical product: tecr1515 parietex rigid py 15x15cm x1 (lot# skf00630).(b)(4).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 laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced recurrence, obliterated internal ring w/ balls of mesh embedded into the spermatic cord and pieces of mesh above the cord, hematoma, hydroceles, edema, cord lipoma, pain, scarring, wad of mesh, anatomy completely attenuated, swelling, tenderness, nausea, less frequent stools, and cellulitis.Post-operative patient treatment included revision surgery, removal of mesh, pain medication, orchiectomy, and hernia repair with new mesh.
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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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Manufacturer Narrative
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Additional information: b5, d8, e1 (facility name, street 1, city, region, postal code), g1 (mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), g3, 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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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced adhesions, mesh migration, recurrence, obliterated internal ring w/ balls of mesh embedded into the spermatic cord and pieces of mesh above the cord, hematoma, hydroceles, edema, cord lipoma, pain, scarring, wad of mesh, anatomy completely attenuated, swelling, tenderness, nausea, less frequent stools, and cellulitis.Post-operative patient treatment included revision surgery, removal of mesh, pain medication, orchiectomy, and hernia repair with new mesh.
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Manufacturer Narrative
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Additional information: h6(patient codes) 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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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced adhesions, mesh migration, recurrence, obliterated internal ring w/ balls of mesh embedded into the spermatic cord and pieces of mesh above the cord, hematoma, hydroceles, edema, cord lipoma, pain, scarring, wad of mesh, anatomy completely attenuated, swelling, tenderness, nausea, less frequent stools, abnormal wbc/hematocrit, inflammation, and cellulitis.Post-operative patient treatment included revision surgery, removal of mesh, pain medication, orchiectomy, ultrasound, and hernia repair with new mesh.Relevant tests/laboratory data: (b)(6) 2014: testicular ultrasound showed large left scrotal hematoma.Blood work abnormal for wbc 15.1, hematocrit 39.9 (b)(6) 2015: scrotal ultrasound showed bilateral hydroceles, l>r with debris noted within the left.Scrotal skin thickened, may represent edema or cellulitis.
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Manufacturer Narrative
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Additional information: h6, additional codes no code e2402 meshoma.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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