KOH CUP KCP-30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-12 for KOH CUP KCP-30 manufactured by Coopersurgical, Inc..

Event Text Entries

[872456] A lavh was started, but aborted. The koh cup was left in the pt. The pt complained of a vaginal discharge, but no pain. The pt returned to the ob/gyn who performed an external exam. The pt eventually returned to the primary physician who performed an internal exam removing the koh cup. The pt was treated with a vaginal wash and prescribed antibiotics. The procedure has been reported to have occurred in 2007.
Patient Sequence No: 1, Text Type: D, B5


[8006177] In keeping with good medical practice, it is the responsibility of the physician to ensure all non-implantable devices are removed from the pt.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1216677-2008-00018
MDR Report Key1059861
Report Source06
Date Received2008-06-12
Date of Report2008-06-09
Date Mfgr Received2008-05-12
Date Added to Maude2009-09-24
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 FDA0
Event Location0
Manufacturer ContactTHOMAS WILLIAMS
Manufacturer Street95 CORPORATE DR.
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKOH CUP
Generic NameCOLPOTOMIZER SYSTEM
Product CodeHDM
Date Received2008-06-12
Model NumberKCP-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer AddressTRUMBULL CT US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-06-12

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