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

Model Number MDS139009

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

Patient Problem Chemical Exposure (2570)

Event Date 02/03/2023

Event Type  Injury  

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 Description

According to the facility a hot pack exploded in the nurse's eyes and face when attempting to activate it.

• Brand Name: MEDLINE
• Type of Device: 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
• MDR Text Key: 309877423
• Report Number: 1417592-2023-00065
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10888277320550
• UDI-Public: 10888277320550
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other