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

Model Number PCOPM15

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Prolapse (2475); No Code Available (3191)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post parastomal hernia wherein sugarbaker technique was used, a reoperation was performed following a reoccurrence of hernia of a patient who used mesh.At that time, there was a round hole of about 5 cm around the center of the center band and the hernia reoccurred.It was confirmed that the mesh was under adhering to the abdominal wall around the hole.The hernia was closed with suture and the operation was completed.

Manufacturer Narrative

Evaluation summary: no sample was returned for investigation; however, a photo was provided.The visual examination of the provided picture (video camera) shows a well-integrated mesh placed in the abdominal wall.However due to the picture quality, it is not possible to determine where exactly is located the hole in the mesh (2d-band or 3d-band), if it is a tear or a cut, and if the mesh have been overstretched or not.Without the sample a detailed investigation could not be performed.The root cause could not be determined.As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with qa specifications for all product lots prior release to market.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PARIETEX
• 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: 8059538
• MDR Text Key: 126888955
• Report Number: 9615742-2018-02539
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177758
• UDI-Public: 10884521177758
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081126
• 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
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCOPM15
• Device Catalogue Number: PCOPM15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention