MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11443-012B

Device Problem Burst Container or Vessel (1074)

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

Event Date 01/01/1980

Event Type  malfunction  

Manufacturer Narrative

No samples were returned for evaluation; therefore, a root cause could not be determined.A review of the device history record could not be performed as a lot number was not provided.Cardinal health will continue to monitor and trend all similar reported product related issues.

Event Description

Customer reported employee said that hot pack exploded on her wrist above the gloves.She is not sure of the exact date it happened, but know it was in april.She washed off the contents from the hot pack, but most of the product was on the floor.The lot number is not available, and the hot pack was discarded.No injury /adverse effect noted.

• Brand Name: HOT PACK, LARGE, 6X9IN
• 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: 17122308
• MDR Text Key: 317272848
• Report Number: 1423537-2023-00950
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• 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
• Report Date: 06/13/2023

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: Health Professional
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/13/2023
• 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
• Patient Sex: Female