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

Model Number PCO12

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Scarring (2061); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

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 incarcerated ventral hernia. It was reported that after implant, the patient experienced infection, chronic non-healing wound, scarring, fibrosis, inflammation, and large wad of mesh with sutures largely unincorporated. Post-operative patient treatment included removal of mesh due to chronic mesh infection and chronic non-healing wound.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 incarcerated ventral hernia. It was reported that after implant, the patient experienced infection, chronic non-healing wound, scarring, and large wad of mesh with sutures largely unincorporated. Post-operative patient treatment included removal of mesh due to chronic mesh infection and chronic non-healing wound.

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a hernia repair with mesh. She had revision surgery 2 years post-surgery. The patient experienced removal of mesh due to chronic mesh infection and chronic non-healing wound.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• 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, CT 80301 ; 3035816943
• MDR Report Key: 7140544
• MDR Text Key: 247300325
• Report Number: 9615742-2017-06148
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2015
• Device Model Number: PCO12
• Device Catalogue Number: PCO12
• Device Lot Number: PKC00384
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2017 Patient Sequence Number: 1