MAUDE Adverse Event Report: COVIDIEN HL WMR 3. 5X5 W/TAB 25/B 100/C; HEEL WARMER

Model Number MH00002T

Device Problems Burst Container or Vessel (1074); Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a heel warmer.The customer states when the product was squeezed it came out of the package and caused a minor burn to a staff member.

• Brand Name: HL WMR 3. 5X5 W/TAB 25/B 100/C
• Type of Device: HEEL WARMER
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6330217
• MDR Text Key: 67606230
• Report Number: 1219103-2017-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2017

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: Health Professional
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Device Lot Number: 631338X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1