MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PACK,HOT,INSTANT,LRG,6X9"

Model Number	MDS139009
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Integrity Problem (2978)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility a hot pack exploded in the nurse's eyes and face when attempting to activate it.No additional information is available at this time.The sample is available but has not been returned for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility a hot pack exploded in the nurse's eyes and face when attempting to activate it.

• Brand Name: MEDLINE
• Common Device Name: PACK,HOT,INSTANT,LRG,6X9"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16403940
• Report Number: 1417592-2023-00065
• Device Sequence Number: 12107085
• Product Code: IMD
• UDI-Device Identifier: 10888277320550
• UDI-Public: 10888277320550
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MDS139009
• Device Catalogue Number: MDS139009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown