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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1510
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Emotional Changes (1831); Fistula (1862); Impotence (1925); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Skin Discoloration (2074); Ulceration (2116); Discharge (2225); Ulcer (2274); Discomfort (2330); Injury (2348); Depression (2361); Disability (2371); Impaired Healing (2378); Inadequate Pain Relief (2388); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Sexual Dysfunction (4510); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/16/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter: the patient underwent a laparoscopic hernia procedure for an inguinal hernia.The surgeon repaired both sides, right and left, with mesh.Since the surgery the patient had been experiencing sharp pains and uncomfortable feelings in the pelvic, hip, and groin area.The right side was so bad that the patient had not been able to lift their leg to get in the car.The patient was no able to bend all the way down to tie their shoes.The patient was unable to lift their leg without the aid of their hands to pull it up.Last year, the symptoms had worsened on the left side.The patient said the left side "felt like a brillo pad was breaking up into pieces under the surface of my skin." there were 4-5 noticeable uncomfortable lumps under the skin.The patient could not put on pants or underwear without being in pain.The patient stated it was depressing.The patient was not able to have sex for months even before the bulge got bigger and still to this present day.After about another month the lumps turned into one big bulge extending from the hip area and the other in the groin area.After about another month the bulge turned purple, red, and black.The patient went to the emergency room and a cat scan was done.They saw scar tissue.The bulge was leaking in two different areas, one in the hip and one in the groin.The patient was prescribed antibiotics and pain medicine for about a month.The patient was referred by their primary care doctor to a surgeon to have things looked at and possibly remove the mesh.The patient had a surgery scheduled and had been in excruciating pain for the past 6 months.The patient's performance at work had slowed down noticeable.It was depressing taking all the pain medication that did not seem to work.Tramadol has bot been that good for the patient.The patient cannot work with a wound vac on or do every day activities.The patient cannot play with their kids like they used to.The patient can barely tie their own shoes because of the infected mesh.The patient was unable to stand for periods at a time without sharp pains shooting down from the hip to the leg making the legs give out unless the patient were to sit down.The patient had to go to the emergency room because the bulge was so big and painful and uncomfortable.It was still draining out of two different areas the patient had to keep changing bandages at the very least twice a day because of the leakage.The patient was hospitalized in 2013 for intestinal blockage due to the hernia mesh.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patients attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after the implant, the patient experienced sharp pains, infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a (b)(6) pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, ulcer, inflammation, staphylococcus aureus, small bowel obstruction, adhesions, drainage, ulceration, cellulitis, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, lysis of adhesions, release of small bowel obstruction, antibiotics, and removal of mesh.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patients attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after the implant, the patient experienced sharp pains, infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a brillo pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, and removal of mesh.
 
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 laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after the implant, the patient experienced infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a brillo pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, ulcer, inflammation, staphylococcus aureus, small bowel obstruction, adhesions, drainage, ulceration, cellulitis, pain, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, lysis of adhesions, release of small bowel obstruction, antibiotics, and removal of mesh.
 
Manufacturer Narrative
Additional information: g3 corrected information: h6 patient codes - e2402 (lumps).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.
 
Manufacturer Narrative
Additional information: b5, g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6(patient codes), no code e2402: non-healing sinus, abnormal wbc.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 laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after the implant, the patient experienced infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a brillo pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, ulcer, inflammation, staphylococcus aureus, small bowel obstruction, adhesions, drainage, ulceration, cellulitis, pain, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, abnormal wbc, non-healing sinus formation in left inguinal hernia area, abscess, fistula, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, wound therapy, lysis of adhesions, release of small bowel obstruction, antibiotics, debridement, exploratory laparotomy, and removal of mesh.Relevant tests/laboratory data: (b)(6) 2013: abnormal wbc 14.9 (b)(6) 2017: pathology report on soft tissue of inguinal region showed skin and subcutis with ulcer, inflammation, and scar.(b)(6) 2017: abnormal lab values of wbc 12.4, hgb 10.9, hct 33.2 (b)(6) 2017: microbiology report showed moderate growth of staphylococcus aureus.(b)(6)2018: pathology report on nonhealing left inguinal wound excision showed skin and subcutaneous tissue with focal acute and chronic inflammation and reactive changes.
 
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Brand Name
PARIETEX
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR   01600
Manufacturer Contact
justin ellis
5920 longbow drive
8200 coral sea st ne
mounds view,mn, CO 55112
7635265677
MDR Report Key6471436
MDR Text Key72088701
Report Number9615742-2017-05072
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model NumberTECR1510
Device Catalogue NumberTECR1510
Device Lot NumberSMJ00794
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/13/2017
Initial Date FDA Received04/07/2017
Supplement Dates Manufacturer Received03/13/2017
06/05/2019
06/05/2019
01/26/2022
02/16/2022
08/02/2023
Supplement Dates FDA Received09/06/2017
12/20/2019
02/26/2020
02/16/2022
03/04/2022
08/08/2023
Date Device Manufactured11/12/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TECR1510(LOT#:SMF00624),UNKABSTACK(LOT#: UNKNOWN)
Patient Outcome(s) Hospitalization; Required Intervention; Other; Disability;
Patient Age30 YR
Patient SexMale
Patient Weight76 KG
Patient RaceBlack Or African American
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