INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-04697
- Event Type
- Injury
- Date Received
- March 22, 2023
- Date of Event
- July 6, 2022
- Report Date
- September 20, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191607674
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADVERSE EVENT PROBLEM: F2203. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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. VISUAL ANALYSIS OF THE PHOTOS IDENTIFIED: - RUPTURE: NOT OBSERVED. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. ADDITIONAL OBSERVATIONS: - RED PARTICLES ON THE SURFACE OF THE SHELL. REFER TO PS-QP-ONEV-115717: COVID-19 QUALITY PLAN - COMPLAINT HANDLING.
THE EVENT OF DELAYED HEALING IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: MALPOSITION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. PAIN: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. DELAYED HEALING: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. SKIN RASH/DERMATITIS: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. VARIED INJURIES-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. MALAISE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. OTHER-MEDICAL-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. EDEMA-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. INFECTION (UNKNOWN ONSET)-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. RESPIRATORY DISORDER-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. PAIN-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5., H.6., H.10.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H6. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. ¿ MALPOSITION: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: ¿ RED PARTICLES ON THE SURFACE OF THE SHELL. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. IT CANNOT BE DETERMINED WHICH DEVICE IS FOR THE LEFT OR RIGHT SIDE PER THE PHOTOS PROVIDED.
PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
PATIENT REPRESENTATIVE LATER REPORTED DELAYED HEALING AND A DEVICE NOT RELATED EVENTS SKIN RASH/DERMATITIS, AUTOIMMUNE/CONNECTIVE TISSUE DISORDER, VARIED INJURIES, MALAISE, EDEMA, INFECTION (UNKNOWN ONSET), RESPIRATORY DISORDER AND PAIN. ALSO, HEALTHCARE PROFESSIONAL CONFIRMED THAT A RUPTURE EVENT DID NOT OCCURRED.
PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449686 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2683735 | 05060191607674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Required Intervention |