MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS INFANT HEEL WARMER SQUEEZE; PACK, HOT OR COLD, DISPOSABLE

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/14/2023

Event Type  malfunction  

Event Description

Customer reported that the infant heel warmer exploded.

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is still under investigation.A follow-up report will be filed once the results have been completed.

• Brand Name: NOVAPLUS INFANT HEEL WARMER SQUEEZE
• 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: 17484602
• MDR Text Key: 320864415
• Report Number: 1423537-2023-00975
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380057588
• UDI-Public: 10885380057588
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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 Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V3A159E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1