MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-FV-14-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-FV-14-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Fluid Discharge (2686)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device evaluation: visual analysis of the returned device identified: opening, red particles in the surface of the shell.Leak test was performed and found opening on radius.A microscopic analysis was performed which identify a striated edge opening, consist with use of a surgical tool and a punctured in the radius side.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: a striated opening in the radius side assessed as surgical damage.A puncture opening on radius due to surgical damage like.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: cellulitis, drainage.
Event or Problem Description
Healthcare professional reported right side cellulitis with persistent drainage.Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FV-14-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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14323219
• Report Number: 9617229-2021-53215
• Device Sequence Number: 5269841
• Product Code: LCJ
• UDI-Device Identifier: 10888628043800
• UDI-Public: 10888628043800
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: 05/08/2025
• Device Model Number: 133S-FV-14-T
• Device Catalogue Number: 133S-FV-14-T
• Device Lot Number: 3443495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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 Sex: Female