MAUDE Adverse Event Report: ALLERGAN (IRVINE) FOURTE EXPANDER FILL SYSTEM; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number UNK FOURTE INJECTOR

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

Sales rep reported on behalf of healthcare professional, "leak coming from the green portion of cap and clear plastic.".

Manufacturer Narrative

Continued d.4 : lot number : fs0158.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for product return: leak coming from the green portion of cap and clear plastic.

• Brand Name: FOURTE EXPANDER FILL SYSTEM
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• 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: 18481183
• MDR Text Key: 332502130
• Report Number: 8043385-2024-00003
• Device Sequence Number: 1
• Product Code: KDD
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• 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