MAUDE Adverse Event Report: NATUS MEDICAL; TOOT SWEET 2ML ORAL 24% SUCROSE

Device Problem Component(s), broken (1103)

Patient Problem Foreign body, removal of (2365)

Event Date 04/24/2015

Event Type  Injury  

Event Description

It was reported by a pediatrician that a small piece of plastic (cap from the sucrose container) from a toot sweet 2ml 24% sucrose container was found in infant's mouth.The sucrose had been used during circumcision.

• Type of Device: TOOT SWEET 2ML ORAL 24% SUCROSE
• Manufacturer (Section D): NATUS MEDICAL; 1501 industrial rd; san carlos CA 94070
• MDR Report Key: 4871990
• MDR Text Key: 6046029
• Report Number: 4871990
• Device Sequence Number: 1
• Product Code: KYX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Other Device ID Number: 4356-1BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other