GUM DROP INFANT PACIFIER 204011N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-27 for GUM DROP INFANT PACIFIER 204011N manufactured by Natus Medical Inc..

Event Text Entries

[66356773] Mother of infant pt provided nursing staff with two infant pacifiers (in addition to the pacifier reported on ((b)(6) 2017) because she noted a hard and jagged clear plastic component was exposed through the surface of the device. The exposed plastic portions were approx 1-2cms and noted to be very sharp. Dates of use: (b)(6) 2016 - (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5067588
MDR Report Key	6293634
Date Received	2017-01-27
Date of Report	2017-01-27
Date of Event	2017-01-19
Date Added to Maude	2017-02-01
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	0
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Sequence Number: 1

Brand Name	GUM DROP INFANT PACIFIER
Generic Name	PACIFIER
Product Code	HCC
Date Received	2017-01-27
Catalog Number	204011N
Lot Number	003374A
Operator	LAY USER/PATIENT
Device Availability	Y
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	NATUS MEDICAL INC.
Manufacturer Address	SEATTLE WA 08108 US 08108

Device Sequence Number: 2

Brand Name	GUM DROP INFANT PACIFIER
Generic Name	PACIFIER
Product Code	HCC
Date Received	2017-01-27
Catalog Number	204012N
Lot Number	003377A
Device Availability	*
Device Eval'ed by Mfgr	*
Device Sequence No	2
Device Event Key	0
Manufacturer	NATUS MEDICAL INC.
Manufacturer Address	SEATTLE WA 08108 US 08108

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-01-27