SIMILAC INFANT NIPPLE AND RING UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-31 for SIMILAC INFANT NIPPLE AND RING UNK manufactured by Ross Products Division Abbott Laboratories.

Event Text Entries

[74344] During bottle feeding, after infant sucked on nipple several times, noted expressed breast milk running down chin. When withdrew nipple, from infant's mouth, noted top of nipple was missing. Unable to locate nipple. Device is nonradiopaque; therefore, facility is unable to determine if the infant swallowed the tip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number144738
MDR Report Key144738
Date Received1997-12-31
Date of Report1997-12-15
Date of Event1997-12-03
Date Facility Aware1997-12-03
Report Date1997-12-15
Date Added to Maude1998-01-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSIMILAC INFANT NIPPLE AND RING
Generic NameNIPPLE
Product CodeFNN
Date Received1997-12-31
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID Number*
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key141122
ManufacturerROSS PRODUCTS DIVISION ABBOTT LABORATORIES
Manufacturer Address625 CLEVELAND AVE. COLUMBUS OH 43216 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-12-31

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