MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-13-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-13-T
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sale reps reported on behalf of healthcare professional left side "infection despite antifungal treatment," ¿full of puss¿ and "a possible pinhole." device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of infection (early onset is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for the event.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: infection (early onset) and rupture.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed an opening on radius assessed as surgical damage.Infection (early onset): unable to observe as it is a medical event not related to the device.Additional observations: yellow particles observed inside the device.
Event or Problem Description
Sale reps reported on behalf of healthcare professional left side "infection despite antifungal treatment," ¿full of puss¿ and "a possible pinhole." device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-13-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: 17212919
• Report Number: 9617229-2023-10557
• Device Sequence Number: 20490488
• Product Code: LCJ
• UDI-Device Identifier: 10888628044197
• UDI-Public: 10888628044197
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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-MX-13-T
• Device Catalogue Number: 133S-MX-13-T
• Device Lot Number: 3598798
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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: Required Intervention
• Patient Sex: Female