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

Catalog Number 3549214

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/05/2018

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that a (b)(6)-year old caucasian female patient underwent primary breast reconstruction with mentor cpx 4 breast tissue expander with suture tabs 550cc breast prostheses.Deflation of the right breast prosthesis was identified.As a result, the patient underwent removal on (b)(6) 2018.

Manufacturer Narrative

On (b)(6) 2018, mentor became aware that the explantation surgery was cancelled and that the tissue expander did not have a leak.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7848708
• MDR Text Key: 119319968
• Report Number: 1645337-2018-05395
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 00081317006749
• UDI-Public: 00081317006749
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Catalogue Number: 3549214
• Device Lot Number: 7575176
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/27/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR