MAUDE Adverse Event Report: N/A; HOT/COLD PACK

Model Number N/A

Device Problems Physical Property Issue (3008); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/31/2016

Event Type  Injury  

Event Description

Customer has had a hot/cold pack for a couple of years, and heated it for 1-1 1/2 minutes.He then applied it to his shoulder for 10 minutes.When he removed it, he noticed it turning red.He went to the emergency room, where he was diagnosed with 2nd degree burns.The end-user reported that he had a cloth barrier between his skin and the pack.There also was not any topical pain relief medication reported as being on the skin prior to the pack application.

• Brand Name: N/A
• Type of Device: HOT/COLD PACK
• MDR Report Key: 5960855
• MDR Text Key: 55096763
• Report Number: 3005182235-2016-00031
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2016
• Distributor Facility Aware Date: 09/01/2016
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention