MAUDE Adverse Event Report: MENTOR TEXAS COLEMAN MINI STYLE I KIT, 19G X 5CM WITH STYLET ; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	COL-MINI I-K
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/27/2019
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.(b)(4).
Event or Problem Description
It was reported by a customer that during a liposuction procedure, a coleman mini infiltration cannula tip broke outside of the patient's body.This issue did not result in any injury to the patient , no delay in procedure, and no need for additional procedure.

• Brand Name: COLEMAN MINI STYLE I KIT, 19G X 5CM WITH STYLET
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8458426
• Report Number: 1645337-2019-09735
• Device Sequence Number: 16250583
• Product Code: MUU
• UDI-Device Identifier: 00081317020363
• UDI-Public: 00081317020363
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: COL-MINI I-K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/27/2019
• Patient Sequence Number: 1