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

Model Number LPG1510X2

Device Problems Degraded (1153); Peeled/Delaminated (1454)

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

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: during a laparoscopic bilateral inguinal hernia repair, the doctor was folding the mesh to implant it into the patient.The doctor folded it to one side and then the other and then dipped the mesh in water/saline to get it slightly wet at which time she noticed the "barrier" peeling away from the mesh.It was not inserted into the patient once the damage to the coating was observed.There was no injury as a result of the event.To resolve the issue they opened up another piece of mesh and used that one.The patient status is alive with no injury.

Manufacturer Narrative

Medtronic complaint number: (b)(4).Evaluation of the device was based on a technical review of all data received from the site, a review of complaint trends and an evaluation of the returned device.The visual examination of the returned sample showed that the mesh was folded and some parts were stuck to the collagen face.The collagen film was incomplete, and the shape of the mesh was modified by a round cut on the white side.Based on the visual examination: the sample was manipulated by the user.The root cause could not be determined.Should new information become available, the file will be opened and the investigation summary amended as appropriate.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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6629597
• MDR Text Key: 77536121
• Report Number: 9615742-2017-05157
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513266
• UDI-Public: 10884521513266
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: LPG1510X2
• Device Catalogue Number: LPG1510X2
• Device Lot Number: PRA2443X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2017
• Date Device Manufactured: 01/26/2017
• 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