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	11/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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 and anxiety-product/procedure.
Event or Problem Description
Healthcare professional reported a right side deflation and exchange of textured breast implants due to the patient¿s concern with the product.Additionally, patient reported right side deflation.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified fold creases, wear abrasion, and a linear opening on the posterior side.A leak test and microscopic analysis were performed which identified a crease smooth opening on the posterior side.The fill test inspection was performed, and the result is no blockage.Based on the device analysis, the final assessment is: a crease smooth opening on the posterior side assessed as a fold flaw opening.Additional, corrected, and/or changed data.
Event or Problem Description
Healthcare professional reported a right side deflation and exchange of textured breast implants due to the patient¿s concern with the product.Additionally, patient reported right side deflation.Device has been explanted.

• 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: 9739347
• Report Number: 9617229-2020-02207
• Device Sequence Number: 1974919
• Product Code: FWM
• UDI-Device Identifier: 10888628000551
• UDI-Public: 10888628000551
• Combination Product (Y/N): N
• Initial Reporter State: LA
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 06/14/2022
• Device Model Number: 68LP-225
• Device Catalogue Number: 68LP-225
• Device Lot Number: 3227880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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: 42 YR