UNK Mammary Implant
Received Jul 27, 2026
Report 9617229-2026-14071 · MDR key 50019639
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
UNK Mammary Implant
Product problems
- Device Appears to Trigger Rejection
- Material Rupture
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Patient reported a rupture. Later through follow up response Healthcare professional confirmed rupture and reported Capsular Contracture, Baker Grade III. This record is for the right side. The device was explanted.
Additional Manufacturer Narrative
This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026The event of Capsular Contracture is a physiological complication and analysis of the device generally does not assist Allergan in determining a probable cause for this event.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: rupture and reported Capsular Contracture, Baker Grade III.Visual Analysis: Rupture: Observed, opening on the device but cannot perform an assessment of the opening as no microscopic analysis can be performed.¿ Capsular Contracture: Unable to observe as it is a medical event that is not related to the device.No additional observations are performed.No further actions are required since no issue in the manufacturing of the device is observed.