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 Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	12/20/2022
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.The reason for reoperation is: "tissue expander was deflated".
Event or Problem Description
Company rep reported via physician right side "tissue expander was deflated".The device remains implanted.
Additional Manufacturer Narrative
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.Reason for reoperation: seroma.
Event or Problem Description
Healthcare professional reported right side "upon entrance into the pocket there was noted to be some seromatous fluid present" and "hole in radius edge." device has been explanted and replaced.
Event or Problem Description
Company rep reported via physician right side "tissue expander was deflated".Later healthcare professional reported right side "upon entrance into the pocket there was noted to be some seromatous fluid present" and "hole in radius edge." device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: observed, opening device in the radius side assessed as unidentified (tear) opening (shell thickness was within specification).Seroma: unable to confirm as it is a medical event not related to the device.Additional observations: yellow particles observed on the surface of the shell.No further actions are required as the device was implanted.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.

• 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: 16098684
• Report Number: 9617229-2022-23934
• Device Sequence Number: 12443084
• Product Code: LCJ
• UDI-Device Identifier: 10888628044029
• UDI-Public: 10888628044029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 04/19/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/08/2023; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG