FDA Adverse Event Injury Summary report: N

MCGHAN

MDR report key: 9558443 · Received December 30, 2019

Report

Report Number
9558443
Event Type
Injury
Date Received
December 30, 2019
Date of Event
December 20, 2019
Report Date
December 27, 2019
Manufacturer
ALLERGAN PLC
Product Code
FTR
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PT WITH HISTORY OF MALIGNANT NEOPLASM OF BREAST. SURGICAL INTERVENTION REQUIRED FOR BILATERAL DEFORMITIES OF THE BREASTS AFTER BILATERAL MASTECTOMIES AND RECONSTRUCTION. PATHOLOGY REPORT (B)(6) 2019, HARDWARE, RIGHT, EXPLANTED SILICONE BREAST IMPLANT, REMOVAL: RECEIVED FRESH IS A 295 G PREVIOUSLY DISRUPTED AND FRAGMENTED 11.5 X 11.5 X 3.0 CM BREAST IMPLANT WITH A DIFFUSELY DISRUPTED WALL, AND YELLOW, GELATINOUS MATERIAL. THE WALL DISPLAYS THE INSCRIPTION "LOT-396271 MCGHAN 400 CC." THERE ARE NO ATTACHED SOFT TISSUES. THE SPECIMEN IS FOR GROSS EXAMINATION ONLY. BREAST, RIGHT, CAPSULECTOMY: RECEIVED IN FORMALIN IS A 8.0 X 7.0 X 3.0 CM AGGREGATE OF TAN-PINK FIBROUS TISSUE WITH FOCAL CAUTERY ARTIFACT. THE INNER ASPECT DISPLAYS CLEAR, COLORLESS ADHERENT GELATINOUS MATERIAL. NO THICKENING OR EXCRESCENCES ARE IDENTIFIED. REPRESENTATIVE SECTIONS ARE SUBMITTED IN 2 CASSETTES. HARDWARE, LEFT, EXPLANTED SILICONE BREAST IMPLANT, REMOVAL: RECEIVED FRESH IS A 402 G, 13.0 X 13.0 X 4.0 CM INTACT BREAST IMPLANT WITH A SMOOTH, CLEAR, COLORLESS INTACT WALL. THE WALL DISPLAYS THE INSCRIPTION "LOT-396251 MCGHAN 400 CC." THE LUMEN CONTAINS CLEAR, COLORLESS GELATINOUS MATERIAL. THERE ARE NO ATTACHED SOFT TISSUES. THE SPECIMEN IS FOR GROSS EXAMINATION ONLY. BREAST, LEFT, CAPSULECTOMY: RECEIVED IN FORMALIN IS A 8.5 X 7.0 X 1.0 CM PORTION OF TAN-PINK FIBROUS TISSUE WITH FOCAL CAUTERY ARTIFACT. THE INNER LINING IS TAN- WHITE TO TAN-PINK, SMOOTH, WRINKLED WITHOUT EXCRESCENCES OR THICKENINGS. REPRESENTATIVE SECTIONS ARE SUBMITTED IN 2 CASSETTES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1323599 MCGHAN BREAST IMPLANT FTR ALLERGAN PLC MCGHAN 400CC 396271

Patients

Seq Age Sex Outcome Treatment
1 58 YR Required Intervention