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	No Code Available (3191)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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 manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient of unknown age underwent a primary breast augmentation with a saline mentor siltex round moderate profile 150cc and experienced deflation on the left breast implant.As a result, the patient will undergo removal of the implants on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor became aware that the patient was scheduled for implant explantation on (b)(6) 2019.Manufacturer¿s reference number: (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: 8375563
• Report Number: 1645337-2019-08911
• Device Sequence Number: 183552
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 12/26/2019
• Device Catalogue Number: 3542615
• Device Lot Number: 7277882
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention