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

Model Number UNKPARUGYTEX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Incontinence (1928); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Manufacturer reference number: (b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Since the lot number was not provided, this information cannot be determined.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative and postoperative diagnosis was menorrhagia, uterine prolapse, symptomatic rectocele, and stress incontinence.The procedure performed was a total vaginal hysterectomy, tension free vaginal taping, intraoperative cystoscopy, and a posterior repair with mesh.The patient underwent an additional procedure on (b)(6) 2007.The preoperative and postoperative diagnosis was sui.The procedure performed was a bioarc sling and cysto.At this time a bioarc sp system with intexan lp, reference# (b)(4), lot# 519392068 was implanted.

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 ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6347820
• MDR Text Key: 67926232
• Report Number: 9615742-2017-05014
• 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
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• 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: 01/25/2017
• 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: MESH
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 91