MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 2 BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	3546112
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2012
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.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).
Event or Problem Description
It was reported that a female patient underwent breast reconstruction with a 350 cc mentor cpx 2 breast tissue expander.The expander was implanted after the patient went through a breast cancer surgery in 2012 and it was reported to have been defective from the beginning and also had leakage.It was also reported that the patient assumed it was perforated during surgery.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.

• Brand Name: MENTOR CPX 2 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8196710
• Report Number: 1645337-2018-07560
• Device Sequence Number: 295442
• Product Code: LCJ
• UDI-Device Identifier: 00081317002192
• UDI-Public: 00081317002192
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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 Catalogue Number: 3546112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other