inforMED
InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 27, 2026 · Event occurred May 11, 2026

Report 9617229-2026-13985 · MDR key 50003653

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Catalog number

68-180

Lot number

3403167

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "rupture". 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: Rupture.This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026