FAN SPRAY KIT N/A 00515047501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for FAN SPRAY KIT N/A 00515047501 manufactured by Zimmer Surgical, Inc..

Event Text Entries

[186723026] This event has been recorded by zimmer biomet under (b)(4). Udi: (b)(4). Evaluation and investigation is in process. Once the investigation is complete, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186723027] It was reported that during the surgery, this complaint product did not work at all on high mode from the start of use. Upon inspection of the device it was discovered that the foreign substance which looks like the deposit from the electrolyte has be attached on the electrodes of the 1 of 8 batteries. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001526350-2020-00324
MDR Report Key9897998
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-04
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-30
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 Received2020-03-30
Model NumberN/A
Catalog Number00515047501
Lot Number64245126
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerZIMMER SURGICAL, INC.
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US 44622


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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