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

Model Number PPM3030

Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic robotic extra preperitoneal ventral henia surgery, when placing mesh, the surgeon not ed excessive memory of the mesh due to the packaging, preventing the mesh from laying flat.When mesh is cut, the memory often makes the mesh edge roll under the back to get back into its folded position.Additional sutures were used to secure the mesh.There was no patient injury.

• Brand Name: PARIETENE
• 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: 12120545
• MDR Text Key: 260036596
• Report Number: 9615742-2021-01671
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521213784
• UDI-Public: 10884521213784
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PPM3030
• Device Catalogue Number: PPM3030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• 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