MAUDE Adverse Event Report: MEDICHOICE INSTANT WARM PACK 5.75 X 5.75; PACK, HOT OR COLD, DISPOSABLE

Lot Number 2103RA52A7

Device Problem Material Rupture (1546)

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

Pt had a heat pack explode while resting on surgical site (back a/p spinal stimulator placement).Pt skin red, irritated.Surgical site intact, dressing changed.Poison control called instructed to wash area with water, no soap.Applied ice pack for comfort, irritated skin kept open to air and dry.

• Brand Name: MEDICHOICE INSTANT WARM PACK 5.75 X 5.75
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• MDR Report Key: 13967667
• MDR Text Key: 288358435
• Report Number: MW5108669
• 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
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Lot Number: 2103RA52A7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White