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

Catalog Number	68HP-650
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional 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.The reason for reoperation: deflation.
Event or Problem Description
Patient reported "i believe the right hand side has ruptured as it's volume is down and noticeable size difference with a protrusion" this is for the right side.The device remains implanted.
Event or Problem Description
Patient reported "i believe the right hand side has ruptured as it's volume is down and noticeable size difference with a protrusion." this is for the right side.The device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4, a6, b3, h6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h6 (explant date not provided).
Event or Problem Description
Device has been explanted and replaced.
Event or Problem Description
Patient reported "i believe the right hand side has ruptured as it's volume is down and noticeable size difference with a protrusion" this is for the right side.Device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d6b.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 17906996
• Report Number: 9617229-2023-16604
• Device Sequence Number: 7543435
• Product Code: FWM
• UDI-Device Identifier: 10888628000476
• UDI-Public: 10888628000476
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/05/2024

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: 02/28/2022
• Device Catalogue Number: 68HP-650
• Device Lot Number: 3186997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 04/04/2024; 05/29/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/01/2024; 04/26/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 64 KG