DIGENE A0040 *

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 2005-12-07 for DIGENE A0040 * manufactured by Coopersurgical, Inc..

Event Text Entries

[414484] During a routine pap sampling, the brush tip separated from the handle remaining in the patient's cervix. The physician located and removed the brush section without injury. There was no add'l medical attention required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2005-00030
MDR Report Key651419
Report Source06
Date Received2005-12-07
Date of Report2005-12-06
Date Added to Maude2005-12-13
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 Location0
Manufacturer ContactTHOMAS WILLIAMS
Manufacturer Street95 CORPORATE DR
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIGENE
Generic NameBRUSH SAMPLER
Product CodeGEE
Date Received2005-12-07
Model NumberA0040
Catalog Number*
Lot NumberCB37Y
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key640889
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address* TRUMBULL CT * US
Baseline Brand NameDIGENE
Baseline Generic NameBRUSH SAMPLER
Baseline Model NoA0040
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-12-07

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