INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-07994
- Event Type
- Injury
- Date Received
- May 9, 2024
- Report Date
- April 15, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUED: A.4. WEIGHT: 62.3 KG E.1. PHONE NUMBER: +(B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT OF "SEROMA-LATE" 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: SEROMA-LATE AND RUPTURE.
CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #1. AWARE DATE SHOULD HAVE BEEN LISTED AS 29/MAY/2024.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5, D.6B, H.6.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RADIAL FOLDS", "CYSTS", "COLLECTION [OF FLUID]", AND "RUPTURE." THE DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RADIAL FOLDS", "CYSTS", "COLLECTION [OF FLUID]", AND "RUPTURE." THE DEVICE HAS BEEN EXPLANTED.
THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1478175 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2833726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |