NO DEVICE
Received Oct 14, 2024
Report 9617229-2024-22569 · MDR key 20441490
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
NO DEVICE - BREAST
Lot number
NI
Product problems
- Device Appears to Trigger Rejection
- Device Appears to Trigger Rejection
Patient
NA · Female
- Capsular Contracture
- Capsular Contracture
Narrative
Additional Manufacturer Narrative
THE 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: CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.
Description of Event or Problem
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Additional Manufacturer Narrative
IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2024-22569, IS A DUPLICATE OF MRN 9617229-2024-24458. PLEASE SEE MRN 9617229-2024-24458 FOR REPORTABLE EVENTS.
Description of Event or Problem
IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2024-22569, IS A DUPLICATE OF MRN 9617229-2024-24458. PLEASE SEE MRN 9617229-2024-24458 FOR REPORTABLE EVENTS.