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

Model Number	133S-FV-12-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Company representative reported "made aware a patient has an infection who had recent breast recon".This is for left side.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformities noted.The event of infection (unknown onset) is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: infection (unknown onset).Fi summary: with the information collected during the investigation, there is enough evidence to support that device serial number (b)(4) was manufactured under controlled conditions in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents related to the reported event.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable, and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run (b)(4) is not related to any additional complaint infection record reported as of today.During the trend review of all infection complaints for the period of mar 2021 through feb 2023, no adverse trend was noted (only pr# (b)(4) in (b)(6) 2021).Given the fact that the cause of the infection cannot be specifically associated to the manufacturing process, and there is not an adverse trend for this type of event, and no er/ ncr(s) or temporary changes were identified during the investigation associated to this lot and the complaint, no corrective action is deemed necessary at this time.

• Brand Name: NATRELLE TE SMOOTH 133S-FV-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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16645732
• Report Number: 9617229-2023-05040
• Device Sequence Number: 17515598
• Product Code: LCJ
• UDI-Device Identifier: 10888628043787
• UDI-Public: 10888628043787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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: 06/01/2017
• Device Model Number: 133S-FV-12-T
• Device Catalogue Number: 133S-FV-12-T
• Device Lot Number: 3626044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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