COLEMAN MINI STYLE I KIT, 19G X 5CM WITH STYLET? COL-MINI I-K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-27 for COLEMAN MINI STYLE I KIT, 19G X 5CM WITH STYLET? COL-MINI I-K manufactured by Mentor Texas.

Event Text Entries

[140121340] 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).
Patient Sequence No: 1, Text Type: N, H10


[140121341] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2019-09735
MDR Report Key8458426
Report SourceUSER FACILITY
Date Received2019-03-27
Date of Report2019-03-01
Date of Event2019-02-27
Date Mfgr Received2019-03-01
Date Added to Maude2019-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. GABRIEL ALFAGEME
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal75038
Manufacturer Phone949789-868
Manufacturer G1MENTOR TEXAS
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOLEMAN MINI STYLE I KIT, 19G X 5CM WITH STYLET?
Generic NameSYSTEM, SUCTION, LIPOPLASTY
Product CodeMUU
Date Received2019-03-27
Catalog NumberCOL-MINI I-K
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMENTOR TEXAS
Manufacturer Address3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-27

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