InjuryFWM

UNK Saline Implant

Received Jul 27, 2026

Report 9617229-2026-13979 · MDR key 50002943

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

Patient reported "one of them ruptured/leaked". This record is for an unknown side. Device remains implanted.

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.Reason for reoperation: deflation.This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.