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

Catalog Number	SMXP135RH
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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
It was reported that four mentor tissue expander devices (two artoura breast tissue expander 500cc devices, one artoura breast tissue expander 535cc device, and one artoura breast tissue expander 700cc device) arrived damaged.The outer shipping box was severely damaged and appeared to be taped together.The damage to the device packaging was not noticed until the shipping box was opened.Device sterility was compromised.The four devices were destroyed and were never used in a patient.There was no patient contact.This medwatch report is for the first of four mentor artoura breast tissue expander devices.
Additional Manufacturer Narrative
On 02/14/2019, mentor received additional information about the event.According to the information received, the implants arrived damaged and it wasn¿t noticed until they were opened.It was confirmed by fedex that they do not have registration of any issue that occurred during transportation.However, according to the serial numbers provided, the products had recent transactions and they have been shipped and returned multiple times, but they haven¿t been repacked or relabeled.Manufacturer 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: 8076160
• Report Number: 1645337-2018-06876
• Device Sequence Number: 2165611
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: No Information
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7599984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/28/2019
• Patient Sequence Number: 1