INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-05589
- Event Type
- Malfunction
- Date Received
- April 6, 2025
- Date of Event
- March 10, 2025
- Report Date
- June 26, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.9, H.3, H.6. DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: TYVEK OR THERMOFORM STICKING: OBSERVED DELAMINATION OF OUTER LID. DELAMINATION: NOT OBSERVED. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: TYVEK OR THERMOFORM STICKING: OBSERVED, DELAMINATION ON THE EXTERNAL THERMOFORMED LID. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DHR TREND SUMMARY: THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENT (A020501 DIFFICULT TO OPEN OR REMOVE PACKAGING MATERIAL). 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: TYVEK AND THERMOFORM STICKING.
HEALTHCARE PROFESSIONAL REPORTED "A PACKAGING MIS-HAP WHILE ... WAS TRYING TO OPEN IT" AND "COULDN'T REMOVE THE IMPLANT FROM THE PACKAGING WITHOUT CONTAMINATING IT." DELAMINATION ON THE EXTERNAL THERMOFORMED LID WAS OBSERVED. DEVICE WAS NOT IMPLANTED. A BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY.
HEALTHCARE PROFESSIONAL REPORTED "A PACKAGING MIS-HAP WHILE ... WAS TRYING TO OPEN IT" AND "COULDN'T REMOVE THE IMPLANT FROM THE PACKAGING WITHOUT CONTAMINATING IT." DELAMINATION ON THE EXTERNAL THERMOFORMED LID WAS OBSERVED. DEVICE WAS NOT IMPLANTED. A BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY.
HEALTHCARE PROFESSIONAL REPORTED "A PACKAGING MIS-HAP WHILE ... WAS TRYING TO OPEN IT" AND "COULDN'T REMOVE THE IMPLANT FROM THE PACKAGING WITHOUT CONTAMINATING IT." DEVICE WAS NOT IMPLANTED. A BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786445 | INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1235882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |