inforMED
InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 27, 2026 · Event occurred Jul 10, 2026

Report 9617229-2026-14138 · MDR key 50036798

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Catalog number

68HP-400

Lot number

2224004

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Patient reported "deflation". Later, healthcare professional reported "Deflation". 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.This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.