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

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.

• 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 Key: 6471436
• Report Number: 9615742-2017-05072
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• Number of Events Reported: 1
• 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

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2017
• Device Model Number: TECR1510
• Device Catalogue Number: TECR1510
• Device Lot Number: SMJ00794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Black Or African American
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Disability