DEROYAL 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 1999-10-27 for DEROYAL 6833-B manufactured by Deroyal Industries, Inc..

Event Text Entries

[184212] After application of umbilical cord clamp, the latch popped open while the infant was still in observation in labor and delivery. Minimal blood loss occurred. A new cord clamp was applied, and no additional treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1055236-1999-00017
MDR Report Key247880
Report Source06
Date Received1999-10-27
Date Reported to FDA1999-10-28
Date Mfgr Received1999-09-30
Device Manufacturer Date1999-04-01
Date Added to Maude1999-11-04
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
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone4239387828
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDEROYAL
Generic NameUMBILICAL CORD CLAMP
Product CodeFOD
Date Received1999-10-27
Model NumberNA
Catalog Number6833-B
Lot Number57062
ID NumberNA
Device Expiration Date2004-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age5 MO
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key240143
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. Other 1999-10-27

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