MAUDE Adverse Event Report: WALGREENS; HOT/COLD CLAY CASED BACK PAD

Device Problem Chemical Spillage (2894)

Patient Problems Chemical Exposure (2570); Partial thickness (Second Degree) Burn (2694)

Event Date 02/06/2017

Event Type  Injury  

Event Description

Used it 4 or 5 more times before it happened.(b)(6), put product in microwave and this time it popped.Didn't see anything splattered in microwave, so pulled it out and then it spilled all over her arm and elbow.She went to the hospital because it was stuck to her and was burning her.Second degree burns.Noticed slit along edge of product by stitching after microwaving.

• Brand Name: WALGREENS
• Type of Device: HOT/COLD CLAY CASED BACK PAD
• MDR Report Key: 6450741
• MDR Text Key: 71525837
• Report Number: MW5068811
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization