MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number UNKNOWN URETEX

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

Patient Problem Injury (2348)

Event Date 02/05/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Pre-op diagnosis: stress urinary incontinence and second degree cystocele.Post-op diagnosis: stress urinary incontinence and second degree cystocele.Name of procedure: transvaginal tape procedure with anterior colporrhaphy.

• Brand Name: UNKNOWN URETEX MESH PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6128779
• MDR Text Key: 60929651
• Report Number: 9615742-2016-00173
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN URETEX
• Device Catalogue Number: UNKNOWN URETEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR