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

Model Number	133S-MV-14-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
Company representative reported "a split at the seam of the te (tissue expander)" and use error against an unknown side.Device has been explanted and replaced.
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.
Additional Manufacturer Narrative
Device photo analysis: visual analysis of the photos identified: deflation: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.It is not possible to determine the lot number or catalog through the photos provided.Additional, changed, and/or corrected data.
Event or Problem Description
Company representative reported "a split at the seam of the te (tissue expander)" and use error against an unknown side.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: one opening observed on anterior side assessed as unidentified (tear) opening (shell thickness was within specification).Use error: unable to observe as it is a medical event not related to the device.Additional observations: creases were observed.Broken observed assessed as surgical damage and missing piece observed of suture tap.No further actions are required as the device was implanted.Additional, changed, and/or corrected data.
Event or Problem Description
Company representative reported "a split at the seam of the te (tissue expander)" and use error against an unknown side.Device has been explanted and replaced.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16513132
• Report Number: 9617229-2023-03435
• Device Sequence Number: 6239761
• Product Code: LCJ
• UDI-Device Identifier: 10888628043886
• UDI-Public: 10888628043886
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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: 09/21/2026
• Device Model Number: 133S-MV-14-T
• Device Catalogue Number: 133S-MV-14-T
• Device Lot Number: 3561429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 06/19/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/05/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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: Required Intervention
• Patient Sex: Female