MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. PACK, HOT, INSTANT, MED ,6X6"; PACK, HOT OR COLD, DISPOSABLE

Model Number MDS139008

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problems Pain (1994); Chemical Exposure (2570)

Event Date 09/05/2022

Event Type  malfunction  

Event Description

An elderly patient being attended to post-gastroparesis/ileus.Patient expressed need for pain relief for back pain and requested a heat pack.Nurse activated heat pack and contents shot out of the top and went into patient's eye and on nurses' clothes and face.Nurse flushed patient's eye/face with no residual issue and no additional treatments required.Nurse experienced no injury and required no treatment, however her scrubs had to be disposed of and replaced.Heat pack was not retained.Patient & nurse had no residual issues.

• Brand Name: PACK, HOT, INSTANT, MED ,6X6"
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15994980
• MDR Text Key: 305595049
• Report Number: 15994980
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDS139008
• Device Catalogue Number: MDS139008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White