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

Model Number	11443-512B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while a nurse was activating a cardinal health hot pack, the pack burst, and gel fell on her.The nurse is okay, and the pack material was removed with soap and water.
Additional Manufacturer Narrative
Dhr reviews were completed on the reported lot.# v1l119 (mfg.Date: 9/15/21).The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.We received 1 sample for evaluation.The sample was already activated.The root cause was determined to be a torn pouch.Cardinal health has initiated capa (b)(4) which will add a warning to the label for the customer to activate away from all people.Cardinal health will also continue to monitor complaint trends.

• Brand Name: HOT PACK, SMALL, 4.5X9IN
• 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 dr; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12901079
• Report Number: 1423537-2021-00693
• Device Sequence Number: 4918604
• Product Code: IMD
• UDI-Device Identifier: 10885380168406
• UDI-Public: 10885380168406
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: 11443-512B
• Device Catalogue Number: 11443-512B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 54 KG