FDA.reportPublic FDA data

MAUDE MDR 893029

MDR report key
893029
Report number
MW5003365
Event key
0
Event type
3
Date received
2007-08-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CURITYNURSING PADTYCO HEALTH CARE GROUPNTCN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-08-130

Event Narratives#

D

Patient 1

CUSTOMER CALLED TO REPORT THAT NYLON BARRIER OF NURSING PAD TORN/PULLED APART INTO SMALL PIECES. SHE WAS CONCERNED ABOUT HER BABY, THAT WHAT IF THE BABY SWALLOWED THE PIECES. ALTHOUGH, NOT HAPPENED. CUSTOMER STATED THAT SHE HAS KEPT THE SUSPECT DEVICE FOR INVESTIGATION IF NEEDED.