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

Catalog Number	3542615
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/04/2018
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.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast reconstruction revision procedure with a mentor siltex round moderate profile 150cc saline breast prosthesis (left device) and a mentor siltex round moderate profile 375cc saline breast prosthesis (right device) when the left breast prosthesis deflated after implantation.The patient woke up and noticed that the left side had deflated.Deflation was confirmed by a visual examination.In addition, the patient reported feeling pain in her left side and capsular contracture (baker grade unknown) in her right breast.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the left breast prosthesis.
Additional Manufacturer Narrative
On 11/02/2018, mentor received additional information about the event.The patient will undergo bilateral explantation on (b)(6) 2018.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 12/20/2018, mentor received additional information about the event.It was initially reported that the patient was scheduled to undergo bilateral explantation on (b)(6) 2018.New information states that the patient will undergo bilateral explantation on (b)(6) 2018.(b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8026929
• Report Number: 1645337-2018-06553
• Device Sequence Number: 1640675
• Product Code: FWM
• UDI-Device Identifier: 00081317001720
• UDI-Public: 00081317001720
• Combination Product (Y/N): N
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2018

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: 02/28/2005
• Device Catalogue Number: 3542615
• Device Lot Number: 155747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 12/20/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/19/2018; 12/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 42 YR