MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number UNKNOWN URETEX

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

Patient Problems Urinary Frequency (2275); Injury (2348)

Event Date 11/21/2003

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).

Event Description

Procedure: tvt, urethropexy and perioperative cystoscopy.The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Pre-op and post-op diagnosis: stress urinary incontinence.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2007: urgency and frequency with urination.On (b)(6) 2008: urinary urgency.On (b)(6) 2013: urinary frequency.

• Brand Name: UNKNOWN URETEX MESH PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• 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 ave; north haven, CT 06473
• MDR Report Key: 6181704
• MDR Text Key: 62601701
• Report Number: 9615742-2016-00202
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/23/2016
• 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 Age: 52 YR
• Patient Weight: 65