MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC DELUXE HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number CN14206, CN14164, RA13288A,

Device Problems Overheating of Device (1437); Difficult or Delayed Activation (2577)

Patient Problem No Information (3190)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

Fifteen of the medline deluxe hot packs did not activate and get hot when folded per manufacturers' instructions.

• Brand Name: DELUXE HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; one medline pl.; mundelein IL 60060
• MDR Report Key: 4820741
• MDR Text Key: 5838433
• Report Number: 4820741
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 06/03/2015

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 Operator: Nurse
• Device Lot Number: CN14206, CN14164, RA13288A,
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1