MAUDE Adverse Event Report: PHILIPS CHILDREN'S MEDICAL VENTURES CHILDREN'S MEDICAL VENTURES; SOOTHIE NEWBORN PACIFIER

Catalog Number 96004-N

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

Concern for potential harm to infant when membrane on pacifier comes out (small hole located in middle of pacifier dislodges).Potential for aspiration.
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manufacturer response for soothie newborn pacifier, children's medical ventures (per site reporter).
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contacted rep and order number was given.

• Brand Name: CHILDREN'S MEDICAL VENTURES
• Type of Device: SOOTHIE NEWBORN PACIFIER
• Manufacturer (Section D): PHILIPS CHILDREN'S MEDICAL VENTURES; 191 wyngate drive; monroeville, PA 15146
• MDR Report Key: 4755195
• MDR Text Key: 22249063
• Report Number: 4755195
• Device Sequence Number: 1
• Product Code: LQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 96004-N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2015
• Patient Sequence Number: 1