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

Model Number	3548216
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/03/2018
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.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 primary breast reconstruction with mentor cpx 4 breast tissue expander 800cc breast prostheses.When the expanders were being replaced with permanent implants, it was discovered by the patient's doctor that the tissue expanders had deflated on both the right and left side.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On 10/26/2018, mentor became aware that the suspect medical device will be retained by the customer.This medwatch form is for the left breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 25, 2022, an analysis of the suspect medical device's photo was completed: investigation summary: upon visual evaluation of the image provided in the complaint, the tissue expander was observed to have a tear on the union between shell and posterior patch.As the product involved in this complaint was retained by the doctor , the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER
• 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 ; 949789-8687
• MDR Report Key: 7987089
• Report Number: 1645337-2018-06278
• Device Sequence Number: 19269284
• Product Code: LCJ
• UDI-Device Identifier: 00081317006572
• UDI-Public: 00081317006572
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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 Model Number: 3548216
• Device Catalogue Number: 3548216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/26/2018; 10/25/2022
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/13/2018; 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female