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

Model Number UGYKA

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Fistula (1862); Hemorrhage/Bleeding (1888); Herpes (1898); Incontinence (1928); Inflammation (1932); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Depression (2361); Prolapse (2475); Blood Loss (2597); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

This event was previously submitted on a summary report ((b)(4)).  subsequently, medtronic has received additional information which is being submitted via this 3500a.This event has been reassessed and found to no longer qualify as a complaint for this device.No issue with the device occurred.Per the implant record, the label was supplied however, it was noted that the ¿bard avaulta anterior biosynthetic support system¿ was ¿opened but not implanted¿.It was placed in the table for reference but this product was not implanted.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment.It was reported that after a procedure where this device was implanted, the patient experienced urinary tract infections, dyspareunia, bleeding or clotting disorders, constipation, cystocele, urinary incontinence, urinary retention, vaginal pain, cystoscopy, diabetic polyneuropathy, depression, herpes zoster, fistulae, bleeding, interstitial cystitis, and bleeding.She required both surgical and nonsurgical interventions.Concomitant devices used include avaulta solo synthetic support system - anterior; align s urethral support system suprapubic.

Manufacturer Narrative

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

• 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: 7685827
• MDR Text Key: 113910230
• Report Number: 9615742-2018-01566
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: ZGJ00030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 117