MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-12-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-12-T
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 return: fibers on implant.
Event or Problem Description
Healthcare professional reported "there are two small pieces of debris within the shell".Device was not implanted.
Event or Problem Description
Healthcare professional reported "there are two small pieces of debris within the shell".Device was not implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: observed like brown hairs, size: around 5cm.A leak test was performed which identified no leakage.A microscopic analysis was performed which identified: device assessed as intact and functional.Also observed on additional analysis observed two brown hairs, size: around 5cm and 2cm, is not consider as workmanship due to the device was not received in the original sealed packaging.Based on the device analysis the final assessment is: device assessed as intact and functional.Two brown hairs, is not considered as workmanship due to the device was not received in the original sealed packaging.
Additional Manufacturer Narrative
Further investigation summary: the review of the documentation associated to the manufacturing process indicates that all devices with work order (b)(4) were released in accordance with allergan medical¿s procedures, and no anomalies were found in the documents related to the reported event.According to the device analysis performed in the laboratory, it was observed hair/fiber on implant which is related to the reported complaint.According to the current risk documents the event of "hair/fiber on implant" is a known failure mode and control measures are stablished to reduce or prevent the incidence of this event.Considering that there is not an 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 taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported "there are two small pieces of debris within the shell".Device was not implanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-12-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10906564
• Report Number: 9617229-2020-19242
• Device Sequence Number: 3043824
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• UDI-Public: 10888628044180
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2021

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 Expiration Date: 11/16/2024
• Device Model Number: 133S-MX-12-T
• Device Catalogue Number: 133S-MX-12-T
• Device Lot Number: 3396970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/01/2020; 01/27/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/29/2020; 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other