MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number 68-480

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

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 05/15/2019

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: deflation.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported right side deflation.Device was explanted.

Event Description

Health professional additionally reported "malposition of implant mildly low and lateral.".

Manufacturer Narrative

Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Device evaluation: visual analysis of the returned device identified: crease fold, wear abrasion and one opening linear on the patch.Leak test and microscopic analysis was performed which identified: one opening sharp on the valve bond edge and one opening striated on the patch.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: a sharp opening on valve bond edge (anterior) due to an unidentified (tear) opening.One striated opening due to surgical damage consist in the use of some surgical tool.The event of malposition is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8968711
• MDR Text Key: 156714349
• Report Number: 9617229-2019-12728
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2010
• Device Catalogue Number: 68-480
• Device Lot Number: 1339675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2019
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR