MAUDE Adverse Event Report: UNKNOWN HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number UN23251-1314

Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 01/04/2024

Event Type  Injury  

Event Description

Went to take hot packs into patient room and then while in pt (patient) room went to pop instant hot pack and the pack exploded in my hands and hot crystals poured between my thumb and upper wrist, on my shoes and the floor.Felt burning sensation instantly on the spot.Rinsed with cold water.Spot remains to have sensation and tender.

• Brand Name: HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18487194
• MDR Text Key: 332778668
• Report Number: MW5150105
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2024

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 Lot Number: UN23251-1314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female