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

Catalog Number	SMXP130RH
Medical Device Problem Codes	Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that a patient was undergoing an unknown procedure with a mentor artoura breast tissue expander 475cc tissue expander when it was noticed that the needle inside the box was not the correct 21 gauge butterfly.The needle inside that box was an 18 gauge with a guide-wire.The correct needle was obtained from the box of a different tissue expander (mentor cpx 4 breast tissue expander with suture tabs tissue expander, catalog #3549213, serial #(b)(4)) and the artoura breast tissue expander 475cc tissue expander was placed in the patient.There was no consequence to the patient.
Additional Manufacturer Narrative
On 08/29/2018, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Correction: in the initial report, device code 2975 ¿manufacturing, packaging, or shipping problem¿ was used.The proper code for this event is 2306 ¿component missing¿.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR 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: 7800053
• Report Number: 1645337-2018-05078
• Device Sequence Number: 1535277
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2018

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 Expiration Date: 06/03/2022
• Device Catalogue Number: SMXP130RH
• Device Lot Number: 7575453
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/29/2018; 06/10/2019
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 08/30/2018; 06/11/2019
• Patient Sequence Number: 1
• Patient Age: 58 YR