MAUDE Adverse Event Report: MENTOR TEXAS HUNSTAD INFILTRATION HANDLE; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	HUN-HAN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
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 manufacturing record evaluation could be performed.D4: udi: as the lot number for the device involved in the event was not provided, the udi is currently not available.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.Reason for device explant and/or reoperation: n/a manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a hunstad infiltration handle leaked during a abdominoplasty surgery.However, the surgery was completed with the handle and without any reported delays.No adverse events or patient consequences were reported.Several follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On march 31, 2025, mentor received the lot number for the suspect medical device.Lot: 23101701.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 19, 2025, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 08, 2025, the mentor analysis lab received the suspect medical device for evaluation.On september 19, 2025, mentor completed an evaluation on the returned device.Device evaluation: the complaint sample of the hunstad infiltration handles was returned to mentor irving after being decontaminated.The complaint samples were sent to the external contract manufacturer primo medical in stoughton massachusetts for further evaluation.Primo medical personnel tested the devices for leaks upon arrival and a leak was identified in the hunstad infiltration handle at the location of the o-ring.The supplier replaced the o-ring with a new one and this resolved the leak.Since the leak in the device was corrected by replacing a consumable part, the defect observed by the customer was not confirmed to be a manufacturing defect.Manufacturer¿s reference number: (b)(4).

• Brand Name: HUNSTAD INFILTRATION HANDLE
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 21634984
• Report Number: 1645337-2025-02872
• Device Sequence Number: 21175220
• Product Code: MUU
• UDI-Device Identifier: 00081317023173
• UDI-Public: (01)00081317023173(10)23101701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K981172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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 Catalogue Number: HUN-HAN
• Device Lot Number: 23101701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 05/19/2025; 09/08/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/21/2025; 05/20/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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
• Patient Sex: Unknown