MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-16-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-16-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
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 reoperation: left side deflation.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening.Leak test was performed and found opening on anterior.A microscopic analysis was performed which identify a punctured in the radius side.The other hole is not analyzed since it was made during the standard process to remove the fluids from the device.Based on the device analysis the final assessment is: a puncture opening on radius due to surgical damage like.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-16-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: 11417471
• Report Number: 9617229-2021-02650
• Device Sequence Number: 17107066
• Product Code: LCJ
• UDI-Device Identifier: 10888628044227
• UDI-Public: 10888628044227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2025
• Device Model Number: 133S-MX-16-T
• Device Catalogue Number: 133S-MX-16-T
• Device Lot Number: 3445130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021; 04/30/2021; 10/13/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/27/2021; 05/27/2021; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• 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: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 50 KG