DYNJ49372A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for DYNJ49372A manufactured by Medline Industries Inc..

Event Text Entries

[106612313] It was reported that the operating (or) towel shed lint during an unidentified cath lab procedure. Per the facility, linting was discovered on an unidentified device after it was wiped with the towel. It is unknown at what point in the procedure the reported towel linting occurred. Per the facility, there was no effect on patient stability. No impact to the procedure was reported. No serious injury, follow-up care, or medical intervention was reported. A sample was received by the manufacturer and the reported product issue was confirmed. Despite good faith efforts to obtain additional information, the facility contact was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer. Due the reported incident and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[106612314] It was reported that the operating room (or) towel shed lint during an unidentified cath lab procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423395-2018-00017
MDR Report Key7439949
Date Received2018-04-18
Date of Report2018-04-18
Date of Event2018-02-15
Date Mfgr Received2018-03-28
Date Added to Maude2018-04-18
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 ContactNIGEL VILCHES
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Manufacturer Phone2249311458
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameANGIO TRAY
Product CodeOEQ
Date Received2018-04-18
Returned To Mfg2018-03-29
Catalog NumberDYNJ49372A
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.