MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-SX-13-T; EXPANDER, SKIN, INFLATABLE

Catalog Number	133S-SX-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported, a right side "the seam was leaking".Device has been explanted.
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 a right side "the seam was leaking and "the device was implanted longer than 6 months." device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ use error: it is observed that the device was implanted approximately ten months.¿ deflation: observed more three openings on anterior side assessed as surgical damage per rga and observed opening on anterior (insert/shell bond edge) side assessed as unidentified (tear) opening.Shell thickness within specification.Additional observations: ¿ no other observations observed.No further actions are required as the device was implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4, a6, b3.
Event or Problem Description
Healthcare professional reported a right side "the seam was leaking and "the device was implanted longer than 6 months." device has been explanted and replaced.

• Brand Name: NATRELLE TE SMOOTH 133S-SX-13-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: 17953873
• Report Number: 9617229-2023-17042
• Device Sequence Number: 6790869
• Product Code: LCJ
• UDI-Device Identifier: 10888628043954
• UDI-Public: 10888628043954
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

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: 09/16/2024
• Device Catalogue Number: 133S-SX-13-T
• Device Lot Number: 3381260
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/15/2023; 01/10/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/26/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2019
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG