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

Model Number	133S-MX-14-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
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.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 deflation.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening and crease flat.Leak test was performed and found opening on anterior.A microscopic analysis was performed which a sharp in the insert shell.Based on the device analysis the final assessment is: a sharp opening on insert shell/bond edge assessed as an unidentified (tear) opening.A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data.
Event or Problem Description
Healthcare professional reported unknown side deflation.Device has been explanted.
Additional Manufacturer Narrative
Further investigation results: the review of the documentation associated to the manufacturing process indicates that all devices were released in accordance with allergan procedures, and no anomalies were found in the documents related to the reported event.According to the device analysis performed in the laboratory, it was observed and unidentified opening on the border of the insert to shell bond area which is related to the reported complaint.According to the current risk documents the event of leakage (or opening) in the insert/shell assembly process is a known failure mode and manufacturing process controls and inspections are stablished to reduce the incidence of this failure mode.
Event or Problem Description
Affected side was the left.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-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: 12176719
• Report Number: 9617229-2021-47014
• Device Sequence Number: 19054409
• Product Code: LCJ
• UDI-Device Identifier: 10888628044203
• UDI-Public: 10888628044203
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2022

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: 01/18/2025
• Device Model Number: 133S-MX-14-T
• Device Catalogue Number: 133S-MX-14-T
• Device Lot Number: 3415939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 12/20/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/20/2021; 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2020
• 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