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

Model Number	SMXP110RH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Local Reaction (2035)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient, who's undergone breast reconstruction revision with a 300cc artoura breast tissue expander on the right breast, suffered breast pain, post-procedure.In addition, the patient is very sore, erythematous, and bruised.The patient reports that the hard base of the implant digs into their skin.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed for the complaint device.The manufacturing record evaluation (mre) was reviewed, 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).
Additional Manufacturer Narrative
On march 12, 2021, mentor received additional information regarding the patient's experience.The patient reported that upon seeing a sample of the tissue expander, it was not as hard as they thought.In addition, the patient reported that their mastectomy site has been damaged by radiation therapy and that their skin is very tight.The patient reported that there is nothing wrong with mentor's device.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: 11418340
• Report Number: 1645337-2021-02331
• Device Sequence Number: 17247501
• Product Code: LCJ
• UDI-Device Identifier: 00081317024293
• UDI-Public: 00081317024293
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021

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: Health Professional
• Device Expiration Date: 06/13/2023
• Device Model Number: SMXP110RH
• Device Catalogue Number: SMXP110RH
• Device Lot Number: 7737417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 04/05/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/01/2021; 04/06/2021
• 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: Other
• Patient Age: 53 YR