ARGYLE 8888750018

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 2017-07-24 for ARGYLE 8888750018 manufactured by Covidien.

Event Text Entries

[80770554]
Patient Sequence No: 1, Text Type: N, H10


[80770556] The customer states that the edlich gastric lavage tube was bent and crimped.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2017-05239
MDR Report Key6735406
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-07-24
Date of Report2017-11-21
Date Mfgr Received2017-07-27
Date Added to Maude2017-07-24
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer Street37 INSURGENTES BLVD A LA P, LA MESA
Manufacturer CityTIJUANA 22225
Manufacturer CountryMX
Manufacturer Postal Code22225
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARGYLE
Generic NameCATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION
Product CodeKDH
Date Received2017-07-24
Returned To Mfg2017-07-27
Model Number8888750018
Catalog Number8888750018
Lot Number170900002
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address37 INSURGENTES BLVD A LA P, LA MESA TIJUANA 22225 MX 22225


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-24

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