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

Model Number TEM1208GR

Device Problem Torn Material (3024)

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

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Implant and explant date were not provided.Since the lot number was not provided, this information cannot be determined.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 an inguinal hernia procedure, before inserting the mesh into the patient, the surgeon was trimming the mesh to the required size and the mesh completely tore in half.The mesh was put to one side and another mesh was opened and used on the patient.The appearance of the mesh was dry.

Manufacturer Narrative

An evaluation was performed on the device.The visual examination of the returned sample shows that the sample was returned in its original packaging: only the inner tyvek pouch was missing.The mesh was found torn from the central pre-cut hole until the opposite edge of the flap.This type of damage would be consistent with high force being applied when opening the flap.It has been cut by the user in particular around the colored yarn marker.The mesh was slightly contaminated by blood.A review of the device history record has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications the root cause of the observed damage was misuse, excessive manipulation/handling rough by the user is highly suspected.Should new information become available the file will be re-opened and the investigation summary is amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6803627
• MDR Text Key: 83031630
• Report Number: 9615742-2017-05205
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177697
• UDI-Public: 10884521177697
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: TEM1208GR
• Device Catalogue Number: TEM1208GR
• Device Lot Number: SQI1087X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• 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