FAN SPRAY KIT 00515047601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-13 for FAN SPRAY KIT 00515047601 manufactured by Zimmer Surgical, Inc..

Event Text Entries

[181553575] This event has been recorded by zimmer biomet under (b)(4). Once an investigation of the device has been completed, a follow-up/final report will be submitted. Udi #: (01) (b)(4), (17) (b)(4), (10) (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[181553576] It was reported that the pulsavac tip disconnected during use. Vibration alone caused the blue locking mechanism to loosen. A piece of the device fell into the patient wound and was retrieved and reassembled to the pulsavac to complete case no additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001526350-2020-00166
MDR Report Key9705685
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-13
Date of Report2020-02-19
Date of Event2020-01-20
Date Mfgr Received2020-02-18
Device Manufacturer Date2019-10-25
Date Added to Maude2020-02-13
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER SURGICAL, INC.
Manufacturer Street200 WEST OHIO AVENUE
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal Code44622
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameFAN SPRAY KIT
Generic NameLAVAGE, JET
Product CodeFQH
Date Received2020-02-13
Returned To Mfg2020-02-03
Catalog Number00515047601
Lot Number64529648
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER SURGICAL, INC.
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US 44622


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-13

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