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

Model Number LPG1510

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2018

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 a robotic inguinal hernia repair, 2 pieces of mesh were damaged.These were not used in the patient.Replaced by new device to complete the case.There was no injury.

Manufacturer Narrative

Evaluation summary: one device was returned.A review of the device history record has been performed by trevoux quality assurance.No failure or ncr that may relate to the reported conditions have been noted.The visual examination of the returned sample shows that: the sample was returned in its original package (commercial box and aluminum pouch).The textile knitting pattern, the mesh dimension and the collagen film were found as expected.Few traces were drawn on the mesh.The mesh has not been cut.The reported condition was not confirmed.It should be noted that the mesh was placed with a robotic-assistance to repair inguinal hernia.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.The reported condition was not confirmed by the returned sample.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROGRIP
• 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: 7943204
• MDR Text Key: 123371728
• Report Number: 9615742-2018-02252
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513136
• UDI-Public: 10884521513136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142900
• 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,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: LPG1510
• Device Catalogue Number: LPG1510
• Device Lot Number: PSC0600X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• 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