MAUDE Adverse Event Report: COVIDIEN HL WMR 3.5X5 NO TAB 25/B 100/C; HEEL WARMER

Model Number MH00002N

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2013 that a customer had an issue with a heel warmer.The customer states that a worker was showing someone how the heel warmers don't seem to be sealed completely.When the worker activated the heel warmer to test it, the heel warmer exploded.This did not land on the worker or cause any harm to the worker.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: HL WMR 3.5X5 NO TAB 25/B 100/C
• Type of Device: HEEL WARMER
• Manufacturer (Section D): COVIDIEN; two ludlow park dr.; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; two ludlow park dr.; chicopee MA 01022
• Manufacturer Contact: janice nevius ; 15 hampshire st; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 3650412
• MDR Text Key: 4350858
• Report Number: 1219103-2014-00004
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MH00002N
• Device Catalogue Number: MH00002N
• Device Lot Number: 326909X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/10/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1