MAUDE Adverse Event Report: MAM PACIFIER; NIPPLE, LAMBS, FEEDING

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 07/23/2017

Event Type  malfunction  

Event Description

A (b)(6) month newborn sucking on pacifier when father noticed the pacifier looked funny.Took pacifier away from infant and noticed plastic nipple detached from plastic posing a high choking risk.Dates of use: (b)(6) 2017.

• Brand Name: PACIFIER
• Type of Device: NIPPLE, LAMBS, FEEDING
• Manufacturer (Section D): MAM
• MDR Report Key: 6740032
• MDR Text Key: 81045236
• Report Number: MW5071213
• Device Sequence Number: 1
• Product Code: FNN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 MO