inforMED
InjuryFWM

Style 68 Saline Filled Breast Implant

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

Report 9617229-2026-14168 · MDR key 50041406

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Catalog number

68HP-550

Lot number

2686201

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "Deflation". This record is for the right side. Device was explanted.

Additional Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time.A review of the Device History Record has been completed. No deviations or non-conformances noted.Reason for reoperation: Deflation.This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026