MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, SMALL, 4.5X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11443-512B

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

Per medwatch report #(b)(4), after popping hot pack, user noted crystalizing substance coming out from hot pack with no injury to the patient.Intended procedure was to place hot pack on arm to help find veins.

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

As no samples were returned for evaluation, a root cause could not be determined.The device history record review was completed on the reported lot v3b181, and the lot was manufactured and released in compliance with all requirements.Cardinal health has made a business decision to close the site which manufactures product 11443-512b and transition to a third-party manufacturer.

• Brand Name: HOT PACK, SMALL, 4.5X9IN
• 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: 18269230
• MDR Text Key: 330673383
• Report Number: 1423537-2023-01002
• Device Sequence Number: 1
• Product Code: IMD
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11443-512B
• Device Catalogue Number: 11443-512B
• Device Lot Number: V3B181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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