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

Model Number	68-700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
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.Dhr trend summary: review of all complaints of fluid leak (a050401) for the period of nov 2020 through oct 2022 related with date opened and found no adverse trend in the event rate with respect to the reported event.Considering that there is not an adverse trend for this type of event no additional actions are deemed required at this time.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: device deflation.
Event or Problem Description
Patient reported left-side "pain" and "leakage.'' device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, d.6a, d.6b, g.2, h.6.
Event or Problem Description
Physician reported a left-side deflation, and observed a "hole, non-specific", and "tear" during surgery.The device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: observed opening on anterior side assessed as fold flaw opening.Pain: unable to observe as it is a medical event not related to the device.Additional observations: observed creases on the device.Observed wear abrasion on the device.No further actions are required as the device was implanted.
Event or Problem Description
Patient reported left side "pain" and "leakage.'' healthcare professional later reported "hole, non-specific" and "tear" as observations made during surgery.Device has been explanted and replaced.

• 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: 15974068
• Report Number: 9617229-2022-22083
• Device Sequence Number: 20572826
• Product Code: FWM
• UDI-Device Identifier: 10888628000322
• UDI-Public: 10888628000322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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: 12/26/2018
• Device Model Number: 68-700
• Device Catalogue Number: 68-700
• Device Lot Number: 2697105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 02/22/2023; 06/13/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/14/2023; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2015
• 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 Sex: Female
• Patient Weight: 82 KG