MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE MODERATE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542912
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) asian female patient underwent an unspecified breast surgery with mentor siltex contour profile moderate 275cc a saline breast prosthesis that deflated post implantation.Deflation of the patient¿s left breast prosthesis was reported.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number:(b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14340995
• Report Number: 1645337-2022-05290
• Device Sequence Number: 20399625
• Product Code: FWM
• UDI-Device Identifier: 00081317001867
• UDI-Public: 00081317001867
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3542912
• Device Catalogue Number: 3542912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian