MAUDE Adverse Event Report: COVIDIEN "WARMERS, INFANT HEEL W/TABS"; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	MH00002T
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the heat pack was being activated.When squeezing the heat pack, it exploded on the arms, scrubs and on the face.A second heat pack was squeezed and the same thing has happened.The product from the heat pack was on the customer, over the floor and a nearby wall and on the table.The customer further stated that the skin was washed and the scrubs were changed.There was no harm to the patient or the staff involved.

• Brand Name: "WARMERS, INFANT HEEL W/TABS"
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 10203212
• Report Number: 1219103-2020-00297
• Device Sequence Number: 14011769
• Product Code: MPO
• UDI-Device Identifier: 30884527004632
• UDI-Public: 30884527004632
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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
• Operator of Device: Other
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Device Lot Number: 005746X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1