THERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS 90001 22-038-820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for THERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS 90001 22-038-820 manufactured by Capitol Vial Inc..

Event Text Entries

[60624073] Based on the initial report, subsequent communication with the reporter and the product identified in the complaint, the device was not used as intended. The intended use of the device is for transport and storage of specimens, not collection of specimens. The device has not been made available to nalge nunc international or capitol vial at this time. Nalge nunc international is seeking additional information from the reporter to further the investigation.
Patient Sequence No: 1, Text Type: N, H10


[60624074] During a procedure to obtain a urine sample, a patient alleges she incurred an injury requiring stitches due to the specimen transport and storage container.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1062700-2016-00001
MDR Report Key6119129
Date Received2016-11-21
Date of Report2016-10-25
Date of Event2016-08-10
Date Mfgr Received2016-10-25
Date Added to Maude2016-11-21
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 ContactCHRISTINE EHMANN
Manufacturer Street75 PANORAMA CREEK DRIVE
Manufacturer CityROCHESTER NY 14625
Manufacturer CountryUS
Manufacturer Postal14625
Manufacturer Phone5858997234
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTHERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER.
Product CodeNNL
Date Received2016-11-21
Model Number90001
Catalog Number22-038-820
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAPITOL VIAL INC.
Manufacturer AddressAUBURN AL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-11-21

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