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

Model Number	SMXP100RH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/18/2020
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 (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.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 underwent a breast reconstruction primary with an artoura breast tissue expander 225cc and suffered from surgical intervention, capsular contracture and an infection on the right breast implant.The patient experienced high pain level, back pain, high blood pressure, hospitalization due to muscle swelling and it was feeling hot, cannot sleep due to pain, all the fluid was in the top two thirds and never went down, spasming, the patient is upset about everything, the patient has to use her left arm for everything.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On 1/11/2021, mentor became aware that section checked other serious in section b2 was checked in error.Manufacturer¿s reference number: (b)(4) section checked other serious in section b2 was checked in error.
Additional Manufacturer Narrative
After clinical review of this file performed on 1/6/2021, it was decided to remove codes capsular contracture and generalized illness to more accurately capture the reported event.Manufacturer¿s reference number: (b)(4) removed codes capsular contracture and generalized illness.

• 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: 11124734
• Report Number: 1645337-2021-00125
• Device Sequence Number: 4606846
• Product Code: LCJ
• UDI-Device Identifier: 00081317024286
• UDI-Public: 00081317024286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/17/2020

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: 08/20/2021
• Device Model Number: SMXP100RH
• Device Catalogue Number: SMXP100RH
• Device Lot Number: 7500421
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 01/06/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/11/2021; 01/25/2021
• 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: Hospitalization; Other
• Patient Age: 65 YR