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

Model Number	PPM1510X3
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); Cough (4457); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: tet1309 parietex std 3d py 13x09cm x1 (lot# src0771x ); abstack30 abs fixation device 30 tacks (lot#n8e0459mx).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias and a supraumbilical ventral hernia.It was reported that after implant, the patient experienced nausea, vomiting, pain, small bowel obstruction, fibrofatty tissue with mild fibrosis, abdominal pain, coughing, bulge, mesh pulled away, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with new mesh, bilateral component separation, sac excised, and mesh removal.
Additional Manufacturer Narrative
Additional info: a4, b5, b7, h6 (patient codes, imf code, ime e2402 updated to: "fibrofatty tissue"), 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias and a supraumbilical ventral hernia.It was reported that after implant, the patient experienced inflammation, adhesions, nausea, vomiting, pain, small bowel obstruction, fibrofatty tissue with mild fibrosis, abdominal pain, coughing, bulge, mesh pulled away, and recurrence.Post-operative patient treatment included ct scan, revision surgery, hernia repair with new mesh,bilateral component separation, sac excised, and mesh removal.

• Brand Name: PARIETENE
• Common Device Name: 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: 11861161
• Report Number: 9615742-2021-01350
• Device Sequence Number: 3663854
• Product Code: FTL
• UDI-Device Identifier: 20884521213828
• UDI-Public: 20884521213828
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PPM1510X3
• Device Catalogue Number: PPM1510X3
• Device Lot Number: SRK0428X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 12/12/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PCO9X PARIETEX PCOX RND 9CM X1 (LOT#PRE0712X); PCO9X PARIETEX PCOX RND 9CM X1 (LOT#PRE0712X)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White