MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. PACK,HOT,INSTANT,LRG,6X9"; PACK, HOT OR COLD, DISPOSABLE

Model Number MDS139009

Device Problem Explosion (4006)

Patient Problems Rash (2033); Blurred Vision (2137)

Event Date 08/30/2021

Event Type  malfunction  

Event Description

Patient had a disposable hot pack explode onto her when she tried to activate it.(contains sodium acetate water.) some went in eyes per patient and on skin.Patient says she rinsed eyes with water and cleaned skin.She has continued blurred vision (reason for admission) and mild rash on chest.

• Brand Name: PACK,HOT,INSTANT,LRG,6X9"
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 12473807
• MDR Text Key: 271453867
• Report Number: 12473807
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/09/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: MDS139009
• Device Catalogue Number: MDS139009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17520 DA