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

Model Number V11450-040B

Device Problem Burst Container or Vessel (1074)

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

Event Date 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for investigation; therefore, an evaluation of the complaint device for deficiency of construction could not be performed and the root cause remains unknown.Device history record review was completed on the reported lot number v2j079.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.No further action will be taken at this time.Cardinal health will continue to monitor complaint trends for this reported issue.

Event Description

Customer reported male patient popped the hot pack himself, and the chemicals leaked on his shirt and hands.Patient encouraged to wash his hands, and he was provided a new shirt.No harm was noted.

• 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: 16474545
• MDR Text Key: 310686862
• Report Number: 1423537-2023-00882
• 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,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2023

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 Operator: Lay User/Patient
• Device Model Number: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: V2J079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2022
• 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
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 66 KG