*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-20 for * manufactured by *.

Event Text Entries

[21066694] The cap came off a urine cup while in transit. Most of specimen leaked into the bio bag.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4735608
MDR Report Key4735608
Date Received2015-02-20
Date of Report2015-02-20
Date of Event2015-02-11
Report Date2015-02-20
Date Reported to FDA2015-02-20
Date Reported to Mfgr2015-04-29
Date Added to Maude2015-04-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameCONTAINER, SPECIMINE, NON-STERILE
Product CodeNNI
Date Received2015-02-20
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-20

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