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

Model Number UNKNOWN MESH PRODUCT

Device Problem Material Erosion (1214)

Patient Problems Micturition Urgency (1871); No Code Available (3191)

Event Date 09/17/2018

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, the patient has previously had an intravaginal slingplasty (ivs) in 2002 which was partially removed later on due to erosion.In 2004, the patient underwent a second surgery with a transobturator (tot) sling for urinary incontinence.Following these two procedures, the patient has had problems with bacteriuria and urgency for a period of a year and a half.Cystoscopy was done and a small area of the bladder was detected to show erosion with mesh which could not be determined whether it relates to the ivs or tot sling.The physician had decided to see how the symptoms would develop.

• Brand Name: UNKNOWN MESH
• 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: 8296645
• MDR Text Key: 134721341
• Report Number: 9615742-2019-00211
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MESH PRODUCT
• Device Catalogue Number: UNKNOWN MESH PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• 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