DRAINAGE WITH REFLUX VALVE DYNC1674 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-04-22 for DRAINAGE WITH REFLUX VALVE DYNC1674 * manufactured by Medline Industries, Inc..

Event Text Entries

[265091] Reported urine in a drainage bag backed up, which could potentially lead to a urinary tract infection. There was no adverse effect on the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2003-00017
MDR Report Key456447
Report Source05,07
Date Received2003-04-22
Date of Report2003-04-08
Date of Event2002-09-28
Date Mfgr Received2003-04-01
Device Manufacturer Date2002-04-01
Date Added to Maude2003-04-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactANDREA HAFERKAMP
Manufacturer StreetONE MEDLINE PLACE
Manufacturer CityMUNDELEIN IL 60060
Manufacturer CountryUS
Manufacturer Postal60060
Manufacturer Phone8478372759
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRAINAGE WITH REFLUX VALVE
Generic NameURINE COLLECTOR
Product CodeEYZ
Date Received2003-04-22
Model NumberDYNC1674
Catalog Number*
Lot Number042802A
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key445436
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PLACE MUNDELEIN IL 60060 US
Baseline Brand NameDRAINAGE BAG W/REFLUX VALVE
Baseline Generic NameURINE COLLECTOR
Baseline Model NoDYNC1674
Baseline Device FamilyDN11
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2003-04-22

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