MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-15-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-15-T
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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 reported unknown side "noticed a hole in the seam".Device was explanted and replaced with a backup.
Event or Problem Description
Healthcare professional reported left side "noticed a hole in the seam".Healthcare professional additionally reported left side "some serous fluid within the tissue expander.".
Additional Manufacturer Narrative
In response to fda report number: (b)(4).Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: observed opening device in the stable base-shell bond edge side assessed as an unidentified (tear) opening.Shell thickness within specification).Use error: unable to confirm as it is a medical event not related to the device.Additional observations: white particles observed in the surface of the shell.No further actions are required as the device was implanted.Additional, changed, and/or corrected data: b5, d6a, d9, e4, g2, h3, h6.The event of "seroma" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: observed opening device in the stable base-shell bond edge side assessed as an unidentified (tear) opening.Shell thickness within specification).Use error: unable to observe as it is related to the time implanted and is not related to the device.Seroma: unable to observe as it is a medical event not related to the device.Additional observations: white particles observed in the surface of the shell.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare professional reported left side "noticed a hole in the seam".Later, healthcare professional reported that there was no mention of seroma on operating procedure report; therefore, seroma was removed as an event.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-15-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: 15962137
• Report Number: 9617229-2022-21850
• Device Sequence Number: 20141074
• Product Code: LCJ
• UDI-Device Identifier: 10888628044210
• UDI-Public: 10888628044210
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2023

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: 02/07/2025
• Device Model Number: 133S-MX-15-T
• Device Catalogue Number: 133S-MX-15-T
• Device Lot Number: 3419825
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 01/17/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/13/2023; 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2020
• 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: 44 YR
• Patient Sex: Unknown
• Patient Weight: 86 KG