STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-03588
- Event Type
- Injury
- Date Received
- February 28, 2023
- Date of Event
- June 18, 2022
- Report Date
- May 10, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191601610
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED A BROKEN OPENING STRIATED ASSESSED AS TO SURGICAL DAMAGE AND MISSING PIECE OF THE SHELL ASSESSED AS TO INCONCLUSIVE. LYMPHADENOPATHY: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: CREASE FLAT OBSERVED IN THE DEVICE. DEFORMATION OBSERVED IN THE DEVICE. YELLOW PARTICLES OBSERVED IN THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.
DEVICE EVALUATION: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT RUPTURE AND LYMPHADENOPATHY WAS REVIEWED ON MARCH 29, 2023. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. LYMPHADENOPATHY: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. PATCH LOT NUMBER 1717111. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. REFER TO PS-QP-ONEV-115717: COVID-19 QUALITY PLAN - COMPLAINT HANDLING.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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. REASON FOR REOPERATION: LYMPHADENOPATHY.
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.
PATIENT REPORTED RIGHT SIDE INTRACAPSULAR RUPTURE. HEALTHCARE PROFESSIONAL REPORTED "BILATERAL MICROMASTIA WITH GLANDULAR PTOSIS", "HYPOPLASTIC GLANDULAR PARENCHYMA WITH INITIAL FIBROUS CHANGES; [ILLEGIBLE] FORMATIONS IN BOTH MAMMARY GLANDS AND ENLARGED LYMPH NODES IN THE AXILLAS BILATERALLY". DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED RIGHT SIDE INTRACAPSULAR RUPTURE. HEALTHCARE PROFESSIONAL REPORTED "BILATERAL MICROMASTIA WITH GLANDULAR PTOSIS", "HYPOPLASTIC GLANDULAR PARENCHYMA WITH INITIAL FIBROUS CHANGES; [ILLEGIBLE] FORMATIONS IN BOTH MAMMARY GLANDS AND ENLARGED LYMPH NODES IN THE AXILLAS BILATERALLY". DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER ADDED LYMPHADENOPATHY. DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED RUPTURE. DEVICE STATUS IS UNKNOWN. THIS RELATES TO THE RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584220 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1717111 | 05060191601610 | |
| 657400 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1717111 | 05060191601610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |