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

Catalog Number MDS139009

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2019

Event Type  malfunction  

Event Description

Warm packs found on the supply cart were unable to be activated.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• MDR Report Key: 8757840
• MDR Text Key: 149948264
• Report Number: 8757840
• 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: 06/10/2019

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 Catalogue Number: MDS139009
• Device Lot Number: CN19045A2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1