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

Model Number	3504311M
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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 700cc mentor tissue expander being used for an unspecified leg surgery ruptured intraoperatively.The expander was used for the patient's left leg and did not inflate with expansion fluid during the surgery.As a result, three tissue expanders (catalog #:3504313m, serial #: (b)(4), ; catalog #: 3504310m, serial #: (b)(4); catalog #: 3504311m, serial #: (b)(4)) were used, and the surgery was completed.No patient consequences or procedural delays were reported.At the time of this report, there is no evidence of a need for additional surgical intervention.It is currently unknown what type of leg procedure the patient underwent with the tissue expander.However, follow-up is still in progress.If additional information is received in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
On 18-mar-2021, it was found that the incorrect event date was reported on the initial report.On 24-mar-2021, the investigation on the suspected medical device was completed.Investigation summary: mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed no damage or anomalies.Leak testing was performed in accordance with the mentor procedures, and the expander was expanded as expected.Additionally, no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number:pc-000850623 on the initial report, the event date was reported as 2-feb-2021.However, the actual event date was 1-feb-2021.The relevant field has been updated.

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11389335
• Report Number: 1645337-2021-02105
• Device Sequence Number: 19654190
• Product Code: LCJ
• UDI-Device Identifier: 00081317002475
• UDI-Public: 00081317002475
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2024
• Device Model Number: 3504311M
• Device Catalogue Number: 3504311M
• Device Lot Number: 9452641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1