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

Model Number	PCO3728X
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Sepsis (2067); Seroma (2069); Hernia (2240); Impaired Healing (2378); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Concomitant product: securestrap (product id: strap25, lot no: lez828), securestrap (product id: strap25, lot no: lcm323), pco3728x parietex pcox 37x28cm x1 (prc0045x), sym15 stex rnd 15cm x1 (ppj1040x).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 therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced exposed mesh, wound dehiscence, non-healing wound, chronic abdominal wound, erosion of mesh into bowel, mesh infection, fistula, recurrence, adhesions, abscess, seroma, poorly incorporated mesh, mesh migration, loss of domain, positive for pyoderma gangrenosum, sepsis, death, and necrotic tissue.Post-operative patient treatment included revision surgeries, mesh resutured, wound vac, wound debridement, removal of mesh, split-thickness skin graft, and hernia repair with new mesh, incision/drainage of abscess, evacuation of seroma, takedown of adhesions, small bowel resection, anastomosis, right flank abdominoplasty with advancement flaps of muscle and skin, transported to the icu, remained intubated because of long duration of open abdomen/comorbidities, and excision of necrotic tissue.Information received indicates the patient is now deceased, due to sepsis.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 11859998
• Report Number: 9615742-2021-01335
• Device Sequence Number: 3973028
• Product Code: FTL
• UDI-Device Identifier: 10884521179653
• UDI-Public: 10884521179653
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 05/20/2021

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: 02/28/2022
• Device Model Number: PCO3728X
• Device Catalogue Number: PCO3728X
• Device Lot Number: PRC0045X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 160