MAUDE Adverse Event Report: MENTOR TEXAS COLEMAN INFILTRATION-STYLE II 9CM CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	COL-II9
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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).
Event or Problem Description
It was reported that, during an unspecified surgical procedure involving a 9 cm coleman infiltration-style cannula, the tip of the device broke during fat injection.The device was subsequently discarded.There were no injuries to the patient or user as a result.
Additional Manufacturer Narrative
On 30-aug-2021, mentor became aware that the initial report incorrectly listed the type of reportable event as "serious injury." there were no reported patient consequences, and as a result h1 has been corrected to "malfunction." manufacturer's reference number: (b)(6) h1 updated from "serious injury" to "malfunction".

• Brand Name: COLEMAN INFILTRATION-STYLE II 9CM CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 12331408
• Report Number: 1645337-2021-08893
• Device Sequence Number: 16818329
• Product Code: MUU
• UDI-Device Identifier: 00081317020264
• UDI-Public: 00081317020264
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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 Model Number: COL-II9
• Device Catalogue Number: COL-II9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1