HYDRO LEMAITRE VALVULOTOME 1009-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[183895016] Disposable valvulotome was opened for vascular bypass surgery. Circulator forgot to check for latex-free compatability. Packaging does not specify whether latex is present. After discovery, the company was called and it was confirmed that this product does contain latex. The surgeon and anesthesiologist were made aware and our monitoring the patient. We are adding a symbol next to this item in our supplies to signal the presence of latex. Manufacturer response for valvulotome, (brand not provided) (per site reporter). The device does contain latex.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9847340
MDR Report Key9847340
Date Received2020-03-18
Date of Report2020-01-24
Date of Event2020-01-23
Report Date2020-01-28
Date Reported to FDA2020-01-28
Date Reported to Mfgr2020-03-18
Date Added to Maude2020-03-18
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYDRO LEMAITRE VALVULOTOME
Generic NameVALVULOTOME
Product CodeMGZ
Date Received2020-03-18
Model Number1009-00
Catalog Number1009-00
Lot NumberELVH1349V
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVENUE BURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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