MAUDE Adverse Event Report: DYNAREX CORPORATION INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number 53654

Device Problem Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/14/2023

Event Type  Injury  

Event Description

Patient burned from hot pack.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): DYNAREX CORPORATION
• MDR Report Key: 17184627
• MDR Text Key: 317733450
• Report Number: MW5118684
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 53654
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other