MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS HOT PACK, MEDIUM, 6X6.5; PACK, HOT OR COLD, DISPOSABLE

Model Number V11450-040B

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

Customer reported medium size heat pack was used off label as an infant heel warmer.Reportedly, the heat pack caused a first-degree burn leaving red blotchy patches on left arm and right leg.

Manufacturer Narrative

The lot number was not provided, and samples were not returned for investigation.Without the lot number, we were unable to review the device history record.With the information provided and no event product returned for investigation, we were not able to determine the root cause.Based on the product number provided, customer used product off-label on an infant; this product is not advertised for use on infants.The manufacturing site will continue to monitor this failure mode for this product.

• Brand Name: NOVAPLUS HOT PACK, MEDIUM, 6X6.5
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13196773
• MDR Text Key: 291751555
• Report Number: 1423537-2022-00716
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2022

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: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Sex: Female
• Patient Weight: 7 KG