MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS; EXPANDER, SKIN, INFLATABLE

Model Number	3547215
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	01/01/2021
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 manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old african american female patient underwent an unspecified breast surgery with a mentor cpx 3 breast tissue expander with suturing tabs 650cc device that deflated post implantation.It was reported that one of the patient¿s breasts is smaller than the other as well as itching underneath the left breast.The patient also developed migraines and swelling on the back.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.The suspect medical device has been implanted in the patient for longer than six months which goes against the product¿s ifu.

• Brand Name: MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12783502
• Report Number: 1645337-2021-12480
• Device Sequence Number: 14540832
• Product Code: LCJ
• UDI-Device Identifier: 00081317003700
• UDI-Public: 00081317003700
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: 09/30/2016
• Device Model Number: 3547215
• Device Catalogue Number: 3547215
• Device Lot Number: 6636668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American