InjuryFWM

UNK Saline Implant

Received Jul 27, 2026

Report 9617229-2026-14007 · MDR key 50009056

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

UNK Saline Implant

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "Deflated-exchange to silicone". This record is for the right side. Device has been explanted.

Additional Manufacturer Narrative

This report was impacted by eMDR scheduled maintenance occurring (b)(6) 2026.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.