Style 68 Saline Filled Breast Implant
Received Jul 27, 2026 · Event occurred Jun 22, 2026
Report 9617229-2026-13964 · MDR key 50000408
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68-420
Lot number
1385346
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 left side. Device was explanted.
Additional Manufacturer Narrative
This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.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.