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

Catalog Number	3542515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/06/2015
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 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.Concomitant products: mentor siltex contour profile spectrum 650cc saline breast implant, catalog # 3542515, lot # 6556524.(b)(4).
Event or Problem Description
It was reported via fda medwatch mw5077747 that a female patient of unknown age underwent breast reconstruction with a saline mentor siltex contour profile spectrum 650cc and experienced change in her digestive system, joint pain, ringing in ears, itching, breast pain and a cough due to newly diagnosed asthma.As a result, the patient underwent removal of the implants on (b)(6) 2018.There was no product issue, such as deflation reported.No additional information has been made available.This is for the left side implant, see manufacturer report number 1645337-2018-05086 for contralateral prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2018, mentor became aware that patient code "pain" was accidentally omitted from the initial report dated (b)(6) 2018.(b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7802285
• Report Number: 1645337-2018-05085
• Device Sequence Number: 14134656
• Product Code: FWM
• UDI-Device Identifier: 00081317002178
• UDI-Public: 00081317002178
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 3542515
• Device Lot Number: 6556524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention