MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-FX-14-T; EXPANDER, SKIN, INFLATABLE

Catalog Number	133S-FX-14-T
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.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.Reason for reoperation: hair/fiber on implant.
Event or Problem Description
Company representative reported "an eye-lash was found in this unopened expander".The device was not implanted.
Event or Problem Description
Company representative reported "an eye-lash was found in this unopened expander".The device was not implanted.
Additional Manufacturer Narrative
Reason for re-operation - not applicable since device was not implanted.
Additional Manufacturer Narrative
Device photo evaluation: visual analysis of the photographs identified, hair/fiber on implant: observed, hair-like fiber on implant.It can¿t be determined, if the package is completely sealed, due to the photos provided.Therefore, it is not assessed as workmanship.However, a further investigation will be requested, to analyze this event.No additional observations are performed.A further investigation is requested, to analyze the event of fiber inside package.
Event or Problem Description
Company representative reported, "an eye-lash was found in this unopened expander".The device was not implanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ hair/fiber on implant: observed hair-like fiber on sealed package.Fiber was sent to an external laboratory, and it was concluded that it is a natural hair.Additional observations: ¿ no other observation observed.Further investigation (b)(6) was opened to analyze the event of hair inside package.
Event or Problem Description
Company representative reported "an eye-lash was found in this unopened expander".The device was not implanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-14-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17997402
• Report Number: 9617229-2023-17329
• Device Sequence Number: 14983230
• Product Code: LCJ
• UDI-Device Identifier: 10888628044043
• UDI-Public: 10888628044043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 133S-FX-14-T
• Device Lot Number: 3662759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023; 11/02/2023; 02/15/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 10/24/2023; 11/27/2023; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female