NUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-07 for NUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER * manufactured by Mead Johnson Nutritionals.

Event Text Entries

[354195] The pt was discovered to have a finger caught in the vent hole of a mead johnson nutritionals nuk newborn orthodontic pacifier-exerciser. The finger had swelled and changed color, and there was difficulty in removing the finger due to the rigid plastic. Blood flow returned to the finger, and the swelling and color change resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1032045
MDR Report Key526483
Date Received2004-05-07
Date of Report2004-05-07
Date of Event2004-05-07
Date Added to Maude2004-05-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER
Generic NameNEWBORN ORTHODONTIC PACIFIER-EXERCISER
Product CodeLQX
Date Received2004-05-07
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key515650
ManufacturerMEAD JOHNSON NUTRITIONALS
Manufacturer Address* EVANSVILLE IN 47721 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2004-05-07

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