GFX-LP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-14 for GFX-LP manufactured by Nagor Ltd..

Event Text Entries

[2422523] Bilateral breast augmentation 1998. In 2000, patient noted difference in right breast, mammogram test and ultrasound suggested no problem. In 2003, patient still concerned about right breast, mammogram and ultrasound repeated, again suggested no problem. In 2004, patient referred back to implanting surgeon, following ultrasound, confirmation of ruptured cohesive gel silicone implant. On explantation implant shell in two pieces, filling completely detached from outer shell. [event reappeared after reintroduction: yes].
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5023869
• MDR Report Key: 2423784
• Date Received: 2012-01-14
• Date of Report: 2012-01-14
• Date of Event: 2005-04-11
• Date Added to Maude: 2012-01-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: GFX-LP
• Generic Name: COHESIVE GEL
• Product Code: NXH
• Date Received: 2012-01-14
• Model Number: GFX-LP
• Lot Number: S3316/1
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NAGOR LTD.
• Manufacturer Address: COOIL RD, ISLE OF MAN BUSINESS PARK, PO BOX 21, GLOBAL HOUSE DOUGLAS IM

Device Sequence Number: 2

• Brand Name: GFX-LP
• Generic Name: COHESIVE GEL
• Product Code: NXH
• Date Received: 2012-01-14
• Model Number: GFX-LP
• Lot Number: S3316/1
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: NAGOR LTD.
• Manufacturer Address: COOIL RD, ISLE OF MAN BUSINESS PARK, PO BOX 21, GLOBAL HOUSE DOUGLAS IM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2012-01-14