MAUDE Adverse Event Report: Allergan (Costa Rica) Style 68 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	68HP-350
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "boob went flat", "i think it had a slow leak for ten years", "had half a boob", "over an inch", "woke up in the morning and the rest of it was gone".This record is for the left side.Device remains implanted.
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.Reason for reoperation: deflation.

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50476614
• Report Number: 9617229-2026-16263
• Device Sequence Number: 13305335
• Product Code: FWM
• UDI-Device Identifier: 10888628000407
• UDI-Public: (01)10888628000407(17)091218
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2009
• Device Catalogue Number: 68HP-350
• Device Lot Number: 1192896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 01/20/2006
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 150 LB