INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-18635
- Event Type
- Injury
- Date Received
- November 3, 2023
- Date of Event
- January 5, 2017
- Report Date
- March 22, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191606707
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE : OBSERVED, OPENING ASSESSED AS FOLD FLAW OPENING. ADDITIONAL OBSERVATIONS: NO PENETRATING NICK (STRESS MARKS). NO FURTHER ACTIONS ARE REQUIRED AS NO ISSUES WITH THE MANUFACTURING PROCESS ARE OBSERVED.
THE EVENT OF "LYMPH NODES OF REACTIVE ASPECT" 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: RUPTURE & LYMPHADENOPATHY.
VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. LYMPHADENOPATHY: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.
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. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.
A HEALTHCARE PROFESSIONAL REPORTED LEFT PROSTHESIS WITH SIGNS OF INTRACAPSULAR RUPTURE, LYMPH NODES OF REACTIVE ASPECT IN LEFT ARMPIT. BI-RADS 2. IT WAS LATER CONFIRMED BY THE HCP CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON ALLERGAN DEVICE.
A HEALTHCARE PROFESSIONAL REPORTED LEFT PROSTHESIS WITH SIGNS OF INTRACAPSULAR RUPTURE, LYMPH NODES OF REACTIVE ASPECT IN LEFT ARMPIT. BI-RADS 2. THE DEVICE REMAINS IMPLANTED.
A HEALTHCARE PROFESSIONAL REPORTED LEFT PROSTHESIS WITH SIGNS OF INTRACAPSULAR RUPTURE, LYMPH NODES OF REACTIVE ASPECT IN LEFT ARMPIT. BI-RADS 2. IT WAS LATER CONFIRMED BY THE HCP CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON ALLERGAN DEVICE.
IT WAS LATER CONFIRMED BY THE HEALTHCARE PROFESSIONAL CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2207822 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1402558 | 05060191606707 | |
| 266357 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1402558 | 05060191606707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Required Intervention |