MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEEL SNUGGLER - 4 BOXES OF 25/CASE

Model Number 99047

Device Problems Tear, Rip or Hole in Device Packaging (2385); Chemical Spillage (2894)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Pr#: (b)(4).A follow up report will be submitted after philips obtains more info concerning this event.

Event Description

It was reported that during deployment for use, the 99047 heel snuggler ripped open and warmer contents spilled onto the infant's face and eyes.Treatment provided was flushing the eyes with water for 20 minutes.This is being considered a serious injury.No further injury/impairment was reported.

• Brand Name: HEEL SNUGGLER - 4 BOXES OF 25/CASE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: greg theokas ; 3000 minuteman rd.; andover, MA 01810 ; 9786871501
• MDR Report Key: 4748803
• MDR Text Key: 15253430
• Report Number: 1218950-2015-02399
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 99047
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1