MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE

Catalog Number	3549314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2017
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant products: left mentor cpx 4 breast tissue expanders with suture tabs 550cc, catalog: 3549314, serial number: (b)(4), lot: 7373970.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent bilateral mastectomy and primary breast reconstruction with mentor cpx 4 breast tissue expanders with suture tabs 550cc.Complications were reported post procedure.As a result, the tissue expanders were explanted from the patient.At the time of this report, mentor has received no information on when the tissue expanders were explanted.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed on 5/15/2018, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7516204
• Report Number: 1645337-2018-02928
• Device Sequence Number: 2678131
• Product Code: LCJ
• UDI-Device Identifier: 00081317006800
• UDI-Public: 00081317006800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 02/19/2021
• Device Catalogue Number: 3549314
• Device Lot Number: 7428803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR