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 05/17/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Procedure: mesh graft/anterior colporrhaphy, tension free tape urethropexy with cystoscopy, perineorrhaphy, and suprapubic catheter placement.Pre-op diagnosis: genuine stress urinary incontinence with fourth degree cystocele, also peroneal defect related to prior obstetric trauma.Post-op diagnosis: genuine stress urinary incontinence with fourth degree cystocele, also peroneal defect related to prior obstetric trauma.

• 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: 6133577
• MDR Text Key: 61083221
• Report Number: 9615742-2016-00178
• 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: 11/02/2016

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
• Device Lot Number: C23293SUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/29/2016
• 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
• Treatment: MESH -2004
• Patient Outcome(s): Other
• Patient Age: 57 YR