MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC ACCU-THERM HOTPACK; PACK,HOT,INSTANT,NON-INSULATED

Model Number MDS138005

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

The hot pack is not getting hot.As soon as it is popped, it will either just stay luke warm or does not get hot at all.Manufacturer response for hot pack, accu-therm (per site reporter).We just now reached out to medline and are awaiting their reply.

• Brand Name: ACCU-THERM HOTPACK
• Type of Device: PACK,HOT,INSTANT,NON-INSULATED
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield IL 60093
• MDR Report Key: 10778402
• MDR Text Key: 214348100
• Report Number: 10778402
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MDS138005
• Device Catalogue Number: MDS138005
• Device Lot Number: VN20095
• 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: 09/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1