InjuryFWM

UNK Mammary Implant

Received Jul 29, 2026

Report 9617229-2026-14305 · MDR key 50070010

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

UNK Mammary Implant

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported through company representative "ruptured implant". This record is for unknown side. The device status is unknown.

Additional Manufacturer Narrative

Clarification Section D: Device information has not been provided. The device has defaulted to a saline device along with coding.Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The reason for reoperation: Deflation.