STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2020-06973
- Event Type
- Injury
- Date Received
- April 14, 2020
- Date of Event
- March 30, 2019
- Report Date
- April 14, 2020
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
IN RESPONSE TO FDA REPORT NUMBER MW 5093399.
THE EVENT OF "LYMPHADENOPATHY" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: LYMPHADENOPATHY.
PATIENT REPORTED VIA REGULATORY AGENCY ¿CONTINUED REDUCED HEALTH RELATED TO NATRELLE ALLERGAN BRAND BREAST IMPLANTS¿, ¿LOST PIGMENTATION OF RIGHT NIPPLE¿, AND ¿SWOLLEN AXIALLY LYMPH GLANDS¿. PATIENT ALSO REPORTED VIA REGULATORY AGENCY ¿DEVELOPED MULTIPLE AUTO IMMUNE DISORDERS¿; THIS IS NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
PATIENT REPORTED VIA REGULATORY AGENCY ¿CONTINUED REDUCED HEALTH RELATED TO NATRELLE ALLERGAN BRAND BREAST IMPLANTS¿, ¿LOST PIGMENTATION OF RIGHT NIPPLE¿, AND ¿SWOLLEN AXIALLY LYMPH GLANDS¿. PATIENT ALSO REPORTED VIA REGULATORY AGENCY ¿DEVELOPED MULTIPLE AUTO IMMUNE DISORDERS¿; THIS IS NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423907 | STYLE 15 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |