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MAUDE MDR 130690

MDR report key
130690
Report number
1423537-1997-00231
Event key
0
Event type
3
Date of event
1997-10-20
Date received
1997-11-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OB PACKOB PACKALLEGIANCE HEALTHCAREMLSSMA12OBFHBSMA12OBFHB279226NYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-11-0701. R

Event Narratives#

D

Patient 1

THE INFANT WAS LESS THAN 3 HRS OLD. THE SURGEON HAD CLAMPED AND CUT THE UMBILICAL CORD THE INFANT WAS THEN PASSED TO THE MOTHER TO SEE HER INFANT. THE NURSE TOOK THE INFANT APPROX 4 FEET TO THE INFANT WARMER FOR ADD'L CLEANING AND ROUTINE. THE RN TURNED TO COMPLETE THE INFANTS CHART AND UPON RETURNING TO THE INFANT NOTICED BLEEDING THROUGH THE INFANTS WRAP. UPON EXAMINATION IT WAS NOTICED THAT THE CORD CLAMP HAD POPPED OFF. A KELLY CLAMP WAS PLACED ON THE UMBILICAL CORD UNTIL ANOTHER CORD CLAMP WAS OBTAINED AND PLACED ON THE INFANT. A FULL CBC BLOOD WORK UP WAS DONE ON THIS INFANT.