MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE ACCU-THERM; PACK, HOT OR COLD, DISPOSABLE

Model Number MDS138005

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 11/14/2017

Event Type  malfunction  

Event Description

Upon activating the hot pack, rn observed on multiple occasions that the pack is too hot for patient use.

• Brand Name: MEDLINE ACCU-THERM
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7709859
• MDR Text Key: 114693298
• Report Number: 7709859
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2018,11/16/2017

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: Health Professional
• Device Model Number: MDS138005
• Device Catalogue Number: MDS138005
• Device Lot Number: CN17230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1