AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

Report

• Report Number: 1018233-2013-01804
• Event Type: Injury
• Date Received: May 8, 2013
• Report Date: April 8, 2013
• Manufacturer: SOFRADIM PRODUCTION
• Product Code: FTL
• Adverse Event: Yes
• Report Source: Distributor report
• Reporter Location: NY, US
• Reporter Occupation: ATTORNEY

Narratives

Description of Event or Problem · 1

IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-01805 AND 1018233-2013-01811.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
202597	AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM		FTL	SOFRADIM PRODUCTION	NA	ZGC00003

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| URETEX TO2 URETHRAL SUPPORT SYSTEM

Terms

Patient problem · 2

• Disability
• Pain

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission