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

Catalog Number UNK FOURTE INJECTOR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Healthcare professional reported "sending expired fourte expander filling system with our tissue expanders." this device was not used.

Manufacturer Narrative

Continued e.1 address line 1: (b)(6).Continued e1 (email address): (b)(6).Clarification d.4: lot number: fs0021 & expiration date: 09/30/2021.Clarification d9 device photos were received.Device photo 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.No further actions are required as no manufacturing issues are observed.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:fourte device was expired and was not used.

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.

Event Description

Healthcare professional reported, "sending expired fourte expander filling system with our tissue expanders".This device was not used.

• Brand Name: FOURTE EXPANDER FILL SYSTEM
• Type of Device: 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: 17928066
• MDR Text Key: 325606107
• Report Number: 8043385-2023-10003
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FOURTE INJECTOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female