inforMED
InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 27, 2026 · Event occurred May 1, 2026

Report 9617229-2026-14114 · MDR key 50031502

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Catalog number

68-390

Lot number

1262150

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "deflation/leak". This record is for the right side. Device remains implanted.

Additional Manufacturer Narrative

This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026A 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.