HUDSON DISP MANUAL RESUS, ADULT W/FLOW DIVERTER 5372

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-16 for HUDSON DISP MANUAL RESUS, ADULT W/FLOW DIVERTER 5372 manufactured by Teleflex Medical.

Event Text Entries

[5716994] The customer alleges that the mask had a failed seal when it was used by the staff for resuscitation of a patient.
Patient Sequence No: 1, Text Type: D, B5


[13235145] Qn #(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2015-00149
MDR Report Key4701816
Report Source06,07
Date Received2015-04-16
Date of Report2015-03-23
Date of Event2015-03-21
Date Mfgr Received2015-03-23
Date Added to Maude2015-06-02
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 FDA0
Event Location0
Manufacturer ContactMARGIE BURTON, RN, REG. AFFAIRS
Manufacturer Street3015 CARRINGTON MILL BLVD.
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street2917 WECK DR.
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON DISP MANUAL RESUS, ADULT W/FLOW DIVERTER
Product CodeNHK
Date Received2015-04-16
Catalog Number5372
Lot Number0912
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer Address2917 WECK DR. RESEARCH TRIANGLE PARK NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-16

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