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

Model Number	11443-012B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Erythema (1840); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample 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.
Event or Problem Description
Customer reported hot pack burst when activating it for a patient.The bag broke and spilt fluid on nurse and patient bed.The nurse washed product off his skin immediately after and reportedly had slight redness; however, no actual injury confirmed.No additional information provided.
Additional Manufacturer Narrative
The original mdr was filed on the wrong product number- v11450-040b.The customer confirmed the correct product number is 11443-012b.Device history record review was completed on the reported lot number v1h103.The lot number 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 investigation.We received one sample for investigation.The sample was already activated.The failure could not be confirmed.The manufacturing site will continue to monitor complaint trends.

• Brand Name: HOT PACK, LARGE, 6X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 12422388
• Report Number: 1423537-2021-00668
• Device Sequence Number: 3779571
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: V1H103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: 08/08/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1