URETEX SUP URETHRAL SUPPORT SYSTEM

Report

• Report Number: 1018233-2013-01566
• Event Type: Injury
• Date Received: April 25, 2013
• Report Date: March 26, 2013
• Manufacturer: SOFRADIM PRODUCTION
• Product Code: OTN
• Adverse Event: Yes
• Report Source: Distributor report
• Reporter Location: FL, US
• Reporter Occupation: ATTORNEY

Narratives

Description of Event or Problem · 1

THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED CYSTOSCOPY, AND VAGINAL CUFF EXPIRATION WITH REMOVAL OF PULLING SUTURES FOR THE PREOPERATIVE DIAGNOSIS OF RECURRENT GENUINE STRESS URINARY INCONTINENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
180735	URETEX SUP URETHRAL SUPPORT SYSTEM		OTN	SOFRADIM PRODUCTION	NA	C23076SUP

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Required Intervention

Terms

Patient problem · 2

• Incontinence
• Injury

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission