MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-12-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-12-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported unknown side deflation.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.Further investigation results: review of dhr for work order 3401145 did not identify any deviations, errors, omissions or non-conformances that may be associated with the reported device event.All tissue expander implants were reviewed as part of the assembly operations and these tasks were performed according to applicable current procedures to ensure that assembly met the required specifications.The dhr assembly report from sap was verified and one device was scrapped during the assembly process (ss) which is not related to the reported event.In addition, dhr for shell runs numbers (b)(4) and (b)(4)did not identify any deviations, errors, omissions or non-conformances during shell fabrication process.All shells were reviewed as part of the shell fabrication operations and these tasks were performed according to applicable current procedures to ensure that fabrication met the required specifications.In addition, the material test records for the insert components were verified per the corresponding procedure, visual and physical inspection were performed, and all components were noted conformant during the testing.Review of work order 3401145 and the event "opening on reinforce to shell bond area" did not identify any ncs or ers associated with this information.Device evaluation: visual analysis of the returned device identified: yellow particles in the surface of the shell and opening.Leak test was performed and found opening on anterior.A microscopic analysis was performed which identify opening sharp in the anterior side.The fill test inspection was performed, the result is no blockage based on the device analysis the final assessment is: a sharp opening on anterior side assessed as to an unidentified (tear) opening 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.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13529732
• Report Number: 9617229-2021-54897
• Device Sequence Number: 20112464
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• UDI-Public: 10888628044180
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/14/2022

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: 12/10/2024
• Device Model Number: 133S-MX-12-T
• Device Catalogue Number: 133S-MX-12-T
• Device Lot Number: 3401145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• 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: Unknown