MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) 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)
Type of Reportable Event	Malfunction
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 reported unknown side leaky expander.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified white particles in device inner surface, missing of suture tab and two curved openings.A microscopic analysis and leak test were performed which identified two opening striated and broken striated of suture tab.Based on the device analysis the final assessment is:two openings striated in the side anterior assessed as surgical damage, broken striated of suture tab assessed as surgical damage, missing of suture tab assessed as inconclusive.
Event or Problem Description
Healthcare professional reported right side leaky expander.Device has been explanted.
Event or Problem Description
Additionally, healthcare professional reported right side.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10712805
• Report Number: 9617229-2020-16823
• Device Sequence Number: 3845419
• Product Code: LCJ
• UDI-Device Identifier: 10888628044036
• UDI-Public: 10888628044036
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2024
• Device Model Number: 133S-FX-13-T
• Device Catalogue Number: 133S-FX-13-T
• Device Lot Number: 3396937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 12/02/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/19/2020; 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention