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

Model Number UGYKA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter: the patient alleged injury.The indication for implantation of transvaginal mesh in this patient was urinary incontinence with cystocele and rectocele, occasional urinary retention.Procedure: underwent cystourethroscopy with sounding, urethrolysis, uretex sling insertion, and mobilization and repair of anterior bladder vesicle and enterocele vaginally grade iii ¿ iv under general anesthesia.Complications post implantation: cystocele, painful urination, urinary, frequency and urinary retention.Additional implant (avaulta) surgery: on (b)(6) 2007 - cystourethroscopy and catheterization, pelvic exam under anesthesia, correction of enterocele and cystocele, grade ii with an avaulta mesh for cystocele and enterocele under general anesthesia.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• 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: 7616123
• MDR Text Key: 111562981
• Report Number: 9615742-2018-01338
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: ZGF00097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Date Device Manufactured: 06/01/2006
• 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
• Patient Age: 43 YR