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

Catalog Number	SMXP135RUH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor product analysis lab has received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
On (b)(6) 2018, a mentor artoura breast tissue expander 700cc device was received by the mentor product analysis lab with no accompanying information.The device could not be associated with an existing complaint.Analysis on this device has begun, but is not complete yet.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, the return of a tissue expander is characteristic of a removal and replacement.As a result, this will be conservatively reported to fda.
Additional Manufacturer Narrative
Device evaluation summary: the device was returned to mentor without fluid inside.No foreign material was observed within the device.Red material was observed on the shell surface.Upon initial inspection, the device appeared intact.No other anomalies were discovered.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.A manufacturing record evaluation (mre) of lot number 7617067 was performed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.There is no evidence that there is any issue related to manufacturing.Mentor products are 100% visually inspected prior to release, in addition to thorough in-process testing during several stages of the manufacturing process.Manufacturer¿s reference number: (b)(4).

• 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: 8205410
• Report Number: 1645337-2018-07663
• Device Sequence Number: 215895
• Product Code: LCJ
• UDI-Device Identifier: 00081317024408
• UDI-Public: 00081317024408
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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?: No
• Operator of Device: No Information
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: SMXP135RUH
• Device Lot Number: 7617067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 12/30/2018
• Supplement Report FDA Received Date: 02/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention