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

Model Number	68LP-225
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional 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.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified: creases, wear abrasion, void >1 mm in non-textured valve-to shell-bond area and one linear opening.Leak test and microscopic analysis was performed which identified: one opening crease smooth.Fill inspection was performed and identified no blockage in the valve.Creases/folding of implant condition that was indicated in the complaint was observed, nevertheless it is considered non-related to the manufacturing process, since the device was received out of their primary packaging and is an explanted device.Based on the device analysis the final assessment is: one opening crease smooth assessed as fold flaw opening and creases/folding of implant condition was observed, nevertheless is not related to the manufacturing process.Reason for reoperation: deflation.
Event or Problem Description
Healthcare professional reported deflation and "any creases".The device was explanted.This record is for the right side.
Additional 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.
Event or Problem Description
Healthcare professional reported deflation and "any creases".The device was explanted.This record is for the right side.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9520135
• Report Number: 9617229-2019-18800
• Device Sequence Number: 11574265
• Product Code: FWM
• UDI-Device Identifier: 10888628000551
• UDI-Public: 10888628000551
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2021
• Device Model Number: 68LP-225
• Device Catalogue Number: 68LP-225
• Device Lot Number: 3035789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR