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

Model Number SYM2015OS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problems Edema (1820); Pain (1994); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 04/03/2017

Event Type  Injury  

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: the patient underwent an open abdominal wall hernia repair procedure.An absorbable tacking device was used to attach the mesh.The patient was discharged from the hospital on the same day of the procedure.Later that night, the patient developed abdominal pain and was hospitalized.A computerized tomography (ct) scan was performed and observed like a dropsy (edema).An ileus tube was placed, however, the symptom did not improve.A reoperation was performed sixteen days after the original procedure.It was observed that the mesh had a hole and part of the intestine, "approximately the half-length of thumb", was getting stuck in the hole.The intestine was not damaged.The surgeon peeled and removed the mesh from the site.The site was treated by manual suturing.The patient is currently in good condition.

Manufacturer Narrative

Evaluation summary: pmv lead an evaluation of the device.The visual examination of the returned sample shows that the sample was returned wrap in a material and placed in an aluminum packaging.Mesh dimension and textile were found as expected, except that they are contaminated by blood.The sewing between both parts of the mesh was found as expected too.19 tacks are attached and placed all around the mesh in the open-skirt.Two holes are visible in the central part.One hole seems to be overstretched, the other hole seems to result from a cut.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: 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 visual examination of the returned sample shows that the sample was returned wrap in a material and placed in an aluminum packaging.Mesh dimension and textile were found as expected, except that they are contaminated by blood.The sewing between both parts of the mesh (central and open-skirt) was found as expected too.19 tacks are attached and placed all around the mesh in the open-skirt (green textile).2 holes are visible in the central part.One hole seems to be overstretched, the other hole seems to result from a cut.The root cause could not be reliably determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• 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 avenue; north haven, CT 06473 ; 2034925563
• MDR Report Key: 6569119
• MDR Text Key: 75263286
• Report Number: 9615742-2017-05127
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131969
• 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,Followup,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: SYM2015OS
• Device Catalogue Number: SYM2015OS
• Device Lot Number: PPG0745X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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; Required Intervention