MAUDE Adverse Event Report: NATRELLE TE SMOOTH 133S-FX-13-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-FX-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/13/2023
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.Dhr trend summary: no patterns were found; therefore, no additional actions are deemed required.The trend of a050401 - fluid/blood leak complaints will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.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: device deflation.
Event or Problem Description
Healthcare professional reported a right side deflation.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9., h.3., h.6.Device evaluation based on the device analysis grid, the assessments of the complaint are: ¿ deflation : observed two opening on the radius side assessed as surgical damage and more than three opening on the anterior side assessed as surgical damage like.No additional observations.
Event or Problem Description
Healthcare professional reported a right side deflation.Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16726837
• Report Number: 9617229-2023-05723
• Device Sequence Number: 20656204
• Product Code: LCJ
• UDI-Device Identifier: 10888628044036
• UDI-Public: 10888628044036
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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 Expiration Date: 10/14/2025
• Device Model Number: 133S-FX-13-T
• Device Catalogue Number: 133S-FX-13-T
• Device Lot Number: 3475638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2020
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG