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

Model Number UNKNOWN MESH PRODUCT

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Constipation (3274)

Event Date 01/01/2004

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, there was migration or expulsion of the device.The patient had severe urinary incontinence, urinary tract infections, left flank pain that radiates down hip and knee, nocturia, constipation, and posterior vaginal mesh erosion.

• Brand Name: UNKNOWN MESH PRODUCT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12760563
• MDR Text Key: 280445253
• Report Number: 9615742-2021-02404
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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: 10/21/2021
• 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