MICROTEK TRANSVAGINAL PROBE COVER PC0907NB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for MICROTEK TRANSVAGINAL PROBE COVER PC0907NB manufactured by Microtek Medical Inc..

Event Text Entries

[138657134] Probe cover broke during exam/use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8415850
MDR Report Key8415850
Date Received2019-03-13
Date of Report2019-03-01
Date of Event2018-09-27
Report Date2019-03-01
Date Reported to FDA2019-03-01
Date Reported to Mfgr2019-03-13
Date Added to Maude2019-03-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROTEK TRANSVAGINAL PROBE COVER
Generic NameCABLE/LEAD/SENSOR/PROBE COVER, NON-STERILE
Product CodeKKX
Date Received2019-03-13
Catalog NumberPC0907NB
Lot Number17262
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICROTEK MEDICAL INC.
Manufacturer Address13000 DEERFIELD PARKWAY, SUITE 300 ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-13

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