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

Model Number	68-650
Medical Device Problem Codes	Fluid/Blood Leak (1250); Peeled/Delaminated (1454)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side deflation.Device remains implanted.
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.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: delamination.
Event or Problem Description
Healthcare professional later reported delamination.The device has been explanted.
Event or Problem Description
Healthcare professional reported left side deflation, particles in valve, and valve delaminated from shell.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9., h.3., h.6.Device evaluation based on the device analysis grid, the assessments of the complaint are: ¿ deflation: one opening observed on posterior side assessed as fold flaw opening.¿ other-technical: particles are observed in the fill channel however they do not obstruct the port holes.¿ delamination: no observed.Additional observations: ¿ creases were observed.¿ yellow biological tissue observed inner the surface of the shell.¿ wear abrasion observed on the surface of the shell.

• 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16791850
• Report Number: 9617229-2023-06688
• Device Sequence Number: 5435929
• Product Code: FWM
• UDI-Device Identifier: 10888628000315
• UDI-Public: 10888628000315
• 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: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2023

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: 02/21/2019
• Device Model Number: 68-650
• Device Catalogue Number: 68-650
• Device Lot Number: 2716904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 09/04/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/23/2023; 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2015
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 54 KG