AMT MINI ONE? ENTERAL EXTENSION SET 8-2455-ISOSAF

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-19 for AMT MINI ONE? ENTERAL EXTENSION SET 8-2455-ISOSAF manufactured by Applied Medical Technology, Inc..

MAUDE Entry Details

Report Number1526012-2019-00002
MDR Report Key9087973
Report SourceHEALTH PROFESSIONAL
Date Received2019-09-19
Date of Report2019-09-16
Date of Event2019-07-09
Date Mfgr Received2019-08-26
Date Added to Maude2019-09-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSARAH BEERCHECK
Manufacturer Street8006 KATHERINE BLVD.
Manufacturer CityBRECKSVILE OH 44141
Manufacturer CountryUS
Manufacturer Postal44141
Manufacturer Phone4402622541
Manufacturer G1APPLIED MEDICAL TECHNOLOGY, INC
Manufacturer Street8006 KATHERINE BLVD
Manufacturer CityBRECKSVILLE OH 44141
Manufacturer CountryUS
Manufacturer Postal Code44141
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMT MINI ONE? ENTERAL EXTENSION SET
Generic NameENTERAL EXTENSION SET
Product CodePIF
Date Received2019-09-19
Returned To Mfg2019-07-22
Model Number8-2455-ISOSAF
Lot Number190604-016
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL TECHNOLOGY, INC.
Manufacturer Address8006 KATHERINE BLVD. BRECKSVILLE OH 44141 US 44141


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-19

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