MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number VN22078-56

Device Problem Burst Container or Vessel (1074)

Patient Problem Abscess (1690)

Event Date 10/30/2022

Event Type  malfunction  

Event Description

The patient requested a disposable heat pack for a right groin abscess.I assisted with activating the heat pack and she placed it at the site; i left the room.Approx 10 minutes after i left, the patient called and said that she thought the heat pack may have burst while in use.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; three lakes drive; northfield IL 60093
• MDR Report Key: 16014146
• MDR Text Key: 305874845
• Report Number: 16014146
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/31/2022

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: VN22078-56
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA
• Patient Sex: Female