NATRELLE TE SMOOTH 133S-MV-14-T, 500CC
Report
- Report Number
- 9617229-2025-00906
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 20, 2024
- Report Date
- June 2, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- LCJ
- PMA / PMN Number
- K182054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: HAIR/FIBER ON IMPLANT: OBSERVED FIBER ON IMPLANT, IT IS NOT ASSESSED AS A WORKMANSHIP SINCE THE PHOTOS SHOW THAT THE DEVICE PACKAGE WAS NOT SEALED, BUT A FURTHER INVESTIGATION IS STILL REQUESTED. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. A FURTHER INVESTIGATION IS REQUESTED FOR THE EVENT OF FIBER INSIDE PACKAGE. FURTHER INVESTIGATION: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES INVOLVED IN THIS WORK ORDER WERE RELEASED IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ADDITIONALLY, NO ER/ NCR(S) WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED WITH THIS LOT AND THE COMPLAINT. ACCORDING TO THE DEVICE ANALYSIS PERFORMED BY PHOTOS IT WAS OBSERVED A FIBER ON IMPLANT. THIS IS EVENT IS NOT CATEGORIZED AS WORKMANSHIP SINCE THE PHOTOS SHOW THAT THE DEVICE PACKAGE WAS NOT SEALED, BUT THIS INVESTIGATION WAS OPENED TO FURTHER ANALYZE, AS THE EVENT WAS CONFIRMED. EVEN THOUGH, THE EVENT IS CONFIRMED, IT IS NOT CONFIRMED AS A HIGH IMPACT COMPLAINT, BECAUSE THE EVENT HAS A SEVERITY OF 3 (SERIOUS) (SEVERITY ESTABLISHED PER MEDICAL REVIEW MR-040207), AND ACCORDING TO PROCEDURE QPP07-01-003-W37 (V6.0) THIS EVENT IS NOT CONSIDERED AS A POTENTIAL HIGH IMPACT COMPLAINT. A REVIEW OF THE CURRENT RISK DOCUMENTS PFMEA-BI PKG AND LBLG REV 13.0 WAS PERFORMED, AND THE EVENT OF HAIR/FIBER ON IMPLANT IS A KNOWN EVENT, FOR WHICH CURRENT PROCESS CONTROLS AND INSPECTIONS ARE ESTABLISHED TO REDUCE THE INCIDENCE OF THIS DEFECT. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH HAIR/FIBER ON IMPLANT WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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: N/A; "CONTAMINATION WITH FOREIGN SUBSTANCE SUCH AS HAIR."
DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ HAIR/FIBER ON IMPLANT: OBSERVED A FIBER ON THE DEVICE, IT IS NOT ASSESSED AS WORKMANSHIP SINCE IT WAS RECEIVED OUT OF THE SEALED PACKAGE. HOWEVER, A FURTHER INVESTIGATION IS STILL REQUESTED. AS PER THE INVESTIGATION PROCEDURE, CREASES WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
HEALTHCARE PROFESSIONAL REPORTED "THERE WAS CONTAMINATION WITH FOREIGN SUBSTANCE SUCH AS HAIR." DEVICE WAS NOT IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "THERE WAS CONTAMINATION WITH FOREIGN SUBSTANCE SUCH AS HAIR." DEVICE WAS NOT IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "THERE WAS CONTAMINATION WITH FOREIGN SUBSTANCE SUCH AS HAIR." DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2009603 | NATRELLE TE SMOOTH 133S-MV-14-T, 500CC | EXPANDER, SKIN, INFLATABLE | LCJ | ALLERGAN (COSTA RICA) | 1184756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |