MENTOR SILTEX ROUND MODERATE PROFILE 3542650

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-30 for MENTOR SILTEX ROUND MODERATE PROFILE 3542650 manufactured by Mentor Texas.

MAUDE Entry Details

• Report Number: 1645337-2019-24750
• MDR Report Key: 9392275
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-11-30
• Date of Report: 2019-11-11
• Date of Event: 2019-11-04
• Date Mfgr Received: 2019-11-11
• Device Manufacturer Date: 2011-06-07
• Date Added to Maude: 2019-11-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. GABRIEL ALFAGEME
• Manufacturer Street: 3041 SKYWAY CIRCLE NORTH
• Manufacturer City: IRVING TX 75038
• Manufacturer Country: US
• Manufacturer Postal: 75038
• Manufacturer Phone: 949789-868
• Manufacturer G1: MENTOR TEXAS
• Manufacturer Street: 3041 SKYWAY CIRCLE NORTH
• Manufacturer City: IRVING TX 75038
• Manufacturer Country: US
• Manufacturer Postal Code: 75038
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Generic Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Product Code: FWM
• Date Received: 2019-11-30
• Catalog Number: 3542650
• Lot Number: 6479211
• Device Expiration Date: 2015-06-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MENTOR TEXAS
• Manufacturer Address: 3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-11-30