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

Model Number UNKPARUGYTEX

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

Patient Problems Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Date received by mfr: since the lot number was not provided, this information cannot be determined.A good faith effort will be made to obtain the applicable information relevant to the report.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.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.The preoperative diagnosis was grade iii cystocele and grade ii rectocele.The postoperative diagnosis was grade iii cystocele, grade ii rectocele, and grade iii enterocele.The procedure performed was a mesh cystocele and rectocele repair with mesh implantation both anteriorly and posteriorly.At the same time an additional procedure was performed.The preoperative and postoperative diagnosis was recurrent cystocele, recurrent rectocele, and need for urethral support in conjunction with anterior repair and posterior repair.The procedure performed was a tension-free vaginal tape sling and cystoscopy.The patient underwent an additional procedure on (b)(6) 2006.The preoperative and postoperative diagnosis was grade ii enterocele.The procedure performed was an abdominal sacral colpopexy.

Manufacturer Narrative

Tracking number: pe:(b)(4).

Event Description

Alleged complications post device implant: 2010: vaginal discharge, mesh excision and granulation cauterization.Mesh revision surgery: 2012 cystocele repair and enterocele repair, and vaginal cuff suspension, excision of exposed mesh, posterior colporrhaphy, perineorrhaphy and cystoscopy.

Manufacturer Narrative

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

• Brand Name: UNKNOWN PARIETEX UGYTEX 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: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6393662
• MDR Text Key: 69558358
• Report Number: 9615742-2017-05038
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKPARUGYTEX
• Device Catalogue Number: UNKPARUGYTEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BSC ADVANTAGE, MESH
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 78