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

Model Number	3542711
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	09/11/2021
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 (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: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female who underwent primary breast augmentation with a mentor siltex contour profile high, 275cc saline prosthesis experienced left sided deflation post procedure.The patient stated that rupture on the left implant, and patient noticed difference after she had a mammogram examination about 2-3 days later, it was getting softer.Patient visited doctor and she was informed that the left implant has been deflated.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.

• Brand Name: MENTOR SILTEX CONTOUR PROFILE HIGH
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• MDR Report Key: 12616197
• Report Number: 1645337-2021-11343
• Device Sequence Number: 1414542
• Product Code: FWM
• UDI-Device Identifier: 00081317001904
• UDI-Public: 00081317001904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2007
• Device Model Number: 3542711
• Device Catalogue Number: 3542711
• Device Lot Number: 271959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2003
• 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: 55 YR