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

Model Number PCO3728X

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems 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, Conditions Term / Code Not Available (4581)

Event Type  Death  

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 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
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 11859998
• MDR Text Key: 251825514
• Report Number: 9615742-2021-01335
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179653
• UDI-Public: 10884521179653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/05/2021
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 160