NATRELLE INSPIRA FULLPROF 485CC SIZER US
Report
- Report Number
- 9617229-2025-10219
- Event Type
- Malfunction
- Date Received
- June 20, 2025
- Report Date
- March 2, 2026
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- MRD
- UDI-DI
- 10888628009356
- PMA / PMN Number
- K831566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 OR THERMOFORM STICKING.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING SYSTEM IDENTIFIED THAT THERE WAS ANOTHER RECORD FOR UNITS MANUFACTURED ON LOT NUMBER 1212420: - (B)(4): TYVEK OR THERMOFORM STICKING (A020501 DIFFICULT TO OPEN OR REMOVE PACKAGING MATERIAL), USE ERROR (A2301 DEVICE HANDLING PROBLEM). DEVICE NOT RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WAS ONE ADDITIONAL COMPLAINT OF TYVEK OR THERMOFORM STICKING FOR THIS LOT NUMBER, THE DEVICES HAS NOT BEEN RETURNED TO CONFIRM THE EVENT OR TO DETECT A POTENTIAL WORKMANSHIP. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01-004-HER1-G02 REVISION 6.0. 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 EVENTS TYVEK OR THERMOFORM STICKING (A020501 DIFFICULT TO OPEN OR REMOVE PACKAGING MATERIAL), A1801 (CONTAMINATION).
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS TYVEK OR THERMOFORM STICKING WAS RECEIVED ON JANUARY 26, 2026 WITH LOT NUMBER [ONLY THERMOFORM RECEIVED, DEVICE NOT RECEIVED]. PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION. PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ TYVEK OR THERMOFORM STICKING: NOT OBSERVED THROUGH VISUAL INSPECTION. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.
COMPANY REPRESENTATIVE ON BEHALF OF HEALTHCARE PROFESSIONAL REPORTED THE BOX OF THE SIZER WAS MALFUNCTIONING AND REALLY HARD TO OPEN. LATER, HEALTHCARE PROFESSIONAL REPORTED "DEVICE PACKAGING DIFFICULT TO REMOVE, COMPROMISING STERILITY OF IMPLANT", NO PATIENT CONTACT. DEVICE WAS NOT IMPLANTED.
COMPANY REPRESENTATIVE ON BEHALF OF HEALTHCARE PROFESSIONAL REPORTED THE BOX OF THE SIZER WAS MALFUNCTIONING AND REALLY HARD TO OPEN. LATER, HEALTHCARE PROFESSIONAL REPORTED "DEVICE PACKAGING DIFFICULT TO REMOVE, COMPROMISING STERILITY OF IMPLANT", NO PATIENT CONTACT. DEVICE WAS NOT IMPLANTED.
COMPANY REPRESENTATIVE REPORTED THE BOX OF THE SIZER WAS MALFUNCTIONING AND REALLY HARD TO OPEN. LATER, HEALTHCARE PROFESSIONAL REPORTED "DEVICE PACKAGING DIFFICULT TO REMOVE, COMPROMISING STERILITY OF IMPLANT". DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 488990 | NATRELLE INSPIRA FULLPROF 485CC SIZER US | SIZER, MAMMARY, BREAST IMPLANT VOLUME | MRD | ALLERGAN (COSTA RICA) | 1212420 | 10888628009356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |