MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS HOT PACK, LARGE, 6X9; PACK, HOT OR COLD, DISPOSABLE

Model Number V11443-012B

Device Problem Burst Container or Vessel (1074)

Patient Problem Skin Burning Sensation (4540)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

We had another package open up and spill on employee¿s hand.No injury; however, it did get all over her hand and was pretty hot.She immediately washed the contents off.

Manufacturer Narrative

Device history record review was completed on the reported lot number, v2c018.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.We received one sample for evaluation, and it was already activated.The root cause was determined to be torn pouch which resulted from improper machine set up.The responsible employee was retrained.A cross-functional team has been established to closely monitor burst complaints; the team is focused on identifying root causes of failure for samples returned to minimize reoccurrence.Cardinal health will continue to monitor for similar reports.

• Brand Name: NOVAPLUS HOT PACK, LARGE, 6X9
• 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: 14278539
• MDR Text Key: 290656595
• Report Number: 1423537-2022-00762
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167218
• UDI-Public: 10885380167218
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V11443-012B
• Device Catalogue Number: V11443-012B
• Device Lot Number: V2C018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 70 KG