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

Model Number	V11450-040B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history review could not be verified as lot number was not provided.No sample was returned for evaluation, therefore a root cause could not be determined.We will continue to monitor this failure mode for this product.
Event or Problem Description
Customer reported that the nurse activated the hot pack by squeezing and the outer package ruptured allowing contents to leak out onto hands.Contents was washed off with soap and water.There was no injury.

• Brand Name: NOVAPLUS HOT PACK, MEDIUM, 6X6.5
• Common Device Name: 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: 13795665
• Report Number: 1423537-2022-00738
• Device Sequence Number: 12010310
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown