PNEUMOSTAT 16100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-03 for PNEUMOSTAT 16100 manufactured by Atrium Medical Corporation.

MAUDE Entry Details

Report Number3011175548-2019-00737
MDR Report Key8757535
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-03
Date of Report2019-07-02
Date of Event2019-06-19
Date Mfgr Received2019-08-15
Device Manufacturer Date2019-01-15
Date Added to Maude2019-07-03
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 Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal03054
Manufacturer G1ATRIUM MEDICAL CORPORATION
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal Code03054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePNEUMOSTAT
Generic NameBOTTLE, COLLECTION, VACUUM
Product CodeKDQ
Date Received2019-07-03
Returned To Mfg2019-07-09
Model Number16100
Catalog Number16100
Lot Number441183
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerATRIUM MEDICAL CORPORATION
Manufacturer Address40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-03

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