NO DEVICE
Report
- Report Number
- 9617229-2025-01897
- Event Type
- Injury
- Date Received
- February 4, 2025
- Date of Event
- February 14, 2017
- Report Date
- July 10, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- -
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH EMDR-75142. AWARE DATE SHOULD HAVE BEEN LISTED AS 3/11/2025.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H10.
THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. REASON FOR REOPERATION: SEROMA-LATE, RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5.
PATIENT REPORTING "PERI-IMPLANT FLUID ACCUMULATION, FOCAL THICKENING IN THE LEFT IMPLANT, LOCATED IN THE RETROAREOLAR REGION (5 X 6MM), WITH ITS SIGNIFICANCE CURRENTLY UNCERTAIN, CHRONIC PAIN IN THE LEFT BREAST, ALONG WITH IMPLANT FLIPPING/DISPLACEMENT" DIAGNOSED BY MRI AND ULTRASOUND. HEALTHCARE PROFESSIONAL CONFIRMS "FLUID COLLECTION, IMPLANT RUPTURE, CAUSING LOCALIZED PAIN AND SYSTEMIC ILLNESS.¿¿ DEVICE REMAINS IMPLANTED.
IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2025-01897, IS A DUPLICATE OF MRN 9617229-2025-0000020. PLEASE SEE MRN 9617229-2025-0000020 FOR REPORTABLE EVENTS.
PATIENT REPORTING "PERI-IMPLANT FLUID ACCUMULATION, FOCAL THICKENING IN THE LEFT IMPLANT, LOCATED IN THE RETROAREOLAR REGION (5 X 6MM), WITH ITS SIGNIFICANCE CURRENTLY UNCERTAIN, CHRONIC PAIN IN THE LEFT BREAST, ALONG WITH IMPLANT FLIPPING/DISPLACEMENT" DIAGNOSED BY MRI AND ULTRASOUND. HEALTHCARE PROFESSIONAL CONFIRMS "FLUID COLLECTION, IMPLANT RUPTURE, CAUSING LOCALIZED PAIN AND SYSTEMIC ILLNESS.¿¿ DEVICE REMAINS IMPLANTED.
UN-REPORTING SINCE THIS IS A DUPLICATE FILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1134593 | NO DEVICE | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2713961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention |