DEROYAL UMBILICAL CORD CLAMP 6833-B

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 1999-06-11 for DEROYAL UMBILICAL CORD CLAMP 6833-B manufactured by Deroyal Industries, Inc.

Event Text Entries

[17513083] Swaddled baby was found with blood on his blankets. When the blankets were removed, the umbilical cord clamp was found unlatched off of the umbilical cord. The baby lost approx 75-80cc of blood.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1055236-1999-00004
MDR Report Key227151
Report Source06
Date Received1999-06-11
Date of Report1999-06-10
Date of Event1999-05-12
Date Facility Aware1999-05-12
Report Date1999-06-10
Date Mfgr Received1999-05-12
Device Manufacturer Date1997-12-01
Date Added to Maude1999-06-16
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 Location3
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDEROYAL UMBILICAL CORD CLAMP
Generic NameUMBILICAL CORD CLAMP
Product CodeFOD
Date Received1999-06-11
Model NumberNA
Catalog Number6833-B
Lot Number31038
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key220256
ManufacturerDEROYAL INDUSTRIES, INC
Manufacturer Address200 DEBUSK LANE POWELL TN 37849 US
Baseline Brand NameUMBILICAL CORD CLAMP
Baseline Generic NameUMBILICAL CORD CLAMP
Baseline Model NoNA
Baseline Catalog No6833-B
Baseline IDNA
Baseline Device FamilyUMBILICAL OCCLUSION DEVICE
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 1999-06-11

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