MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number 168-180

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: "rupture" of saline device.

Event Description

A healthcare professional reported "rupture" of a saline device discovered by mammography.This record relates to the left side.The device has been explanted.

Event Description

A healthcare professional reported "rupture" of a saline device discovered by mammography.This record relates to the left side.The device has been explanted.

Manufacturer Narrative

Visual analysis: visual analysis of the photographs identified: deflation: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.It is not possible to determine the lot number or catalog through the photos provided.Additional, changed, and/or corrected data: h6.

Manufacturer Narrative

Visual analysis: device photograph(s) for the device related to the reported event deflation/ crease folding of implant/ wrinkling/flipping was reviewed on 16-may-23.Visual analysis of the photos identified: deflation: not observed.Crease folding of implant: observed.Wrinkling: not observe.Flipping: not observed.Additional observations: red and yellow particles on the surface of the shell.

Event Description

A healthcare professional reported "rupture" of a saline device discovered by mammography.This record relates to the left side.The device has been explanted.

• Brand Name: STYLE 168 SALINE FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15277890
• MDR Text Key: 298423574
• Report Number: 9617229-2022-14156
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/1997
• Device Catalogue Number: 168-180
• Device Lot Number: 2-501396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/1993
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female