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

Model Number PCOPM15

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Tissue Damage (2104); Prolapse (2475); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a patient with a parastomal hernia was cured with sugarbaker about 3 years ago experienced a recurrence.When the doctor opened the surgical site, they saw that there was a hole in the middle of the mesh and it had become a hernia orifice.It seemed that the doctor thought keyhole type might have been used.The incarceration was removed in the first revision surgery, but the hernia was incarcerated and reoccurred, so the second revision surgery was performed and at that time the doctor did not use mesh.Reoperation was required due to the issue.The procedure was converted to an open procedure.There was tissue damage.

• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8053075
• MDR Text Key: 126600184
• Report Number: 9615742-2018-02524
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177758
• UDI-Public: 10884521177758
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCOPM15
• Device Catalogue Number: PCOPM15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• 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