MAUDE Adverse Event Report: ALLERGAN (IRVINE) FOURTE EXPANDER FILL SYSTEM (SMALL TE); EXPANDER, SKIN, INFLATABLE

Catalog Number	F-4444
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clarification d.4: lot number: fs0003, expiration date: 10/31/2020.Continued e1 (email address): (b)(6).Device evaluation: visual analysis of the photographs identified: other-technical: unable to observe since it is not related to the device.No additional observations were carried out.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: no surgery.The expired device was not used.
Event or Problem Description
Healthcare professional reported "allergan sending expired fourte expander filling system with our tissue expanders." the device was not used.
Event or Problem Description
Healthcare professional reported "allergan sending expired fourte expander filling system with our tissue expanders." the device was not used.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b2, h6.

• Brand Name: FOURTE EXPANDER FILL SYSTEM (SMALL TE)
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer (Section G): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17928072
• Report Number: 8043385-2023-10002
• Device Sequence Number: 15040563
• Product Code: LCJ
• UDI-Device Identifier: 10888628043619
• UDI-Public: 10888628043619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: F-4444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other; Required Intervention
• Patient Sex: Unknown