KENDALL KENGUARD 3512 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-26 for KENDALL KENGUARD 3512 * manufactured by The Kendall Co..

Event Text Entries

[179057] Rptr was notified that the bedside drain bags that they were supplying had a malfunctioning anti-reflux valve. Rptr tested this item and agreed with the customer. Rptr notified the mfr's rep, who came here on 6/22/00 and also agreed with the customer. Rep has sent an example back to kendall for evaluation to determine the nature, severity, and scope of the problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1019194
MDR Report Key283831
Date Received2000-06-26
Date of Report2000-06-26
Date of Event2000-06-21
Date Added to Maude2000-07-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKENDALL KENGUARD
Generic Name2 LITER URINARY BEDSIDE DRAIN BAG
Product CodeEYZ
Date Received2000-06-26
Model Number3512
Catalog Number*
Lot Number210542
ID Number*
Device Expiration Date2005-05-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key274664
ManufacturerTHE KENDALL CO.
Manufacturer Address15 HAMPSHIRE ST. MANSFIELD MA 02048 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-06-26

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