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

Model Number UNKNOWN PARIETENE MESH PRODUCT

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Pain (1994); Discomfort (2330); Injury (2348); Disability (2371); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 parastomal hernia.It was reported that after implant, the patient experienced abdominal pain, bulging, bowel issues, personal injuries, pain, suffering, emotional distress, mesh defective, disability, impairment, loss of enjoyment of life, loss of care, and loss of comfort.

• Brand Name: UNKNOWN PARIETENE MESH PRODUCT
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10658657
• MDR Text Key: 210703995
• Report Number: 9615742-2020-02328
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETENE MESH PRODUCT
• Device Catalogue Number: UNKNOWN PARIETENE MESH PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• 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): Other