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

Model Number	SMXP120RH
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2020
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 manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that there was a hair found inside the sterile packaging of 375cc artoura breast tissue expander.The expander did not touch any patient and there was no patient involvement.
Additional Manufacturer Narrative
On june 17, 2020, photo evaluation was completed.Upon visual evaluation of the image provided in the complaint, hair is observed on the paper lid of the thermoform.According to manufacturing investigation, mentor has established procedures to ensure environmental control is maintained.Environmental control is intended to reduce potential contaminants, particulate, and/or foreign matter that may affect the cosmetic appearance or structural integrity of a finished device.The manufacturing records of the lot-serial number provided were identified.The manufacturing records were reviewed, and the manufacturing standards were met prior to the release of this lot.Each product is visually inspected during manufacturing to ensure the product meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 04/03/2020, 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.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: 9889141
• Report Number: 1645337-2020-04922
• Device Sequence Number: 14307440
• Product Code: LCJ
• UDI-Device Identifier: 00081317024309
• UDI-Public: 00081317024309
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 03/12/2020

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: 10/06/2023
• Device Model Number: SMXP120RH
• Device Catalogue Number: SMXP120RH
• Device Lot Number: 9375576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/03/2020; 06/17/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/06/2020; 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1