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

Model Number	133S-FX-12-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/11/2023
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: deflation.
Event or Problem Description
Healthcare professional via regulatory agency reported bilateral breast tissue expanders placed (b)(6) 2022.Upon completion of expansion process and while waiting on second stage reconstruction, right tissue expander spontaneously deflated.Patient returned to or (b)(6) 2023 to remove and replace right expander due to retracting of skin.Linear defect noted in posterior, lateral seam of expander, approximately 1 cm in length.When looking at the anterior surface of the tissue expander, defect was to the left of the superior tab.No other defects noted within the tissue expander upon examination.Event has been captured as deflation.This record is for right side.Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-12-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: 16399516
• Report Number: 9617229-2023-02288
• Device Sequence Number: 5544121
• Product Code: LCJ
• UDI-Device Identifier: 10888628044029
• UDI-Public: 10888628044029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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 Model Number: 133S-FX-12-T
• Device Catalogue Number: 133S-FX-12-T
• Device Lot Number: 3606201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic