MAUDE Adverse Event Report: MENTOR TEXAS LP ARTOURA PLUS, SMOOTH, HIGH PROFILE; EXPANDER, SKIN, INFLATABLE

Model Number	SDC-130H
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Attending md (medical doctor) tested implant for leaks before implanting expander and noted there was a leak.Implant was not used on patient.

• Brand Name: ARTOURA PLUS, SMOOTH, HIGH PROFILE
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS LP; 555 airline drive; coppell TX 75019
• MDR Report Key: 18893157
• Report Number: 18893157
• Device Sequence Number: 17745050
• Product Code: LCJ
• UDI-Device Identifier: 10081317028243
• UDI-Public: (01)10081317028243(17)271024(10)9981228
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/05/2024
• Report Date (Section F): 01/05/2024

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 Model Number: SDC-130H
• Device Catalogue Number: SDC-130H
• Device Lot Number: 9981228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 01/05/2024