ASTORA MINIARC PRO SLING SYSTEM

Report

• Report Number: MW5067162
• Event Type: Injury
• Date Received: January 8, 2017
• Date of Event: February 15, 2016
• Report Date: January 8, 2017
• Manufacturer: ASTORIA WOMEN'S HEALTH LLC
• Product Code: PAH
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Location: CO, US
• Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

HAD SURGERY AND HAD THE MINIARC PRO SLING SYSTEM PUT IN...IMMEDIATELY AFTER SURGERY, MY ORIGINAL SYMPTOMS WERE WORSE AND I HAVE HAD INCREASED PAIN SINCE IMPLANT. MULTIPLE DR. AND ER VISITS. NOW LOOKING AT ADDITIONAL SURGERY TO HAVE THE SLING REMOVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
15207	ASTORA MINIARC PRO SLING SYSTEM	SURGICAL MESH	PAH	ASTORIA WOMEN'S HEALTH LLC	90000261	936407025

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Other| R	BYSTOLIC| RX MEDS: SIMVASTATIN

Terms

Patient problem · 1

• Inadequate Pain Relief

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission