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

Model Number	133S-MV-15-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: broken device.
Event or Problem Description
Representative reported ¿a tab had ripped off the tissue expander¿.Patient contact was made with the device.Device implanted.Side unknown.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d1, d2, d4, d9, e1, e3, h3, h4, h6.Device evaluation: visual analysis of the returned device identified: red particles on the shell, an opening on anterior, broken on suture tab, and missing suture tab (75-100%).Leak test and microscopic analysis was performed which identified: a striated opening on anterior and striated broken on suture tab.Based on the device analysis the final assessment is: a striated opening on anterior assessed as surgical damage.Striated broken on suture tab assessed as surgical damage.Missing on suture tab assessed as inconclusive.
Event or Problem Description
Company representative reported ¿a tab had ripped off the tissue expander¿.Patient contact was made with the device.Device was not implanted.Side unknown.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-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: 15148024
• Report Number: 9617229-2022-13455
• Device Sequence Number: 5589239
• Product Code: LCJ
• UDI-Device Identifier: 10888628043893
• UDI-Public: 10888628043893
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 133S-MV-15-T
• Device Catalogue Number: 133S-MV-15-T
• Device Lot Number: 3569860
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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: Other; Required Intervention
• Patient Sex: Female