InjuryFWM
Style 168 Saline Filled Breast Implant
Received Jul 27, 2026
Report 9617229-2026-13972 · MDR key 50001111
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
168-300
Lot number
2-502701
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Patient reported of the right side device: "deflation". The device was explanted.
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.