MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	TEXP120RH
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.On 12/24/2019, during visual inspection of the device it was observed with no apparent damage.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No anomalies were observed.There is no root cause since no anomaly was reported and no issues/damages were observed.However this can not be conclusively determined, since was not additional detail were received about the complaint.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Reason for device explant and/or reoperation: unknown.(b)(4).
Event or Problem Description
On 10/31/2019, artoura breast tissue expander 375cc was received by the mentor failure analysis lab with no accompanying information.The device was for the right side.The device was marked as "defective," though no specific failure mode was noted.The device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, it will be conservatively reported to fda as an event requiring medical device removal from a patient.

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9532407
• Report Number: 1645337-2019-26098
• Device Sequence Number: 2703875
• Product Code: LCJ
• UDI-Device Identifier: 00081317009467
• UDI-Public: 00081317009467
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: TEXP120RH
• Device Lot Number: 7544173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention