MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN MENTORTISSUE EXPANDERS; EXPANDER, SKIN, INFLATABLE

Catalog Number UNKNOWN MENTORTISSUE EXPANDERS

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

Patient Problems Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that a female who underwent an unspecified breast surgery with an unknown mentor tissue expender prosthesis experienced unknown-sided deflation post procedure.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.

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 manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: na.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Per additional information received on january 25, 2024, indicated that this complaint has been identified as a duplicate of manufacturer report number: 1645337-2023-10618, 1645337-2024-01007, 1645337-2023-10569.A review has been made and this complaint will be converted to no product issue.See manufacturer report number: 1645337-2023-10618, 1645337-2024-01007, 1645337-2023-10569 for final reporting and complete documentation of this event.No further regulatory reporting to us fda will be done in this complaint file.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN MENTORTISSUE EXPANDERS
• Type of Device: 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18574680
• MDR Text Key: 333661313
• Report Number: 1645337-2024-00911
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN MENTORTISSUE EXPANDERS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female