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

Model Number MDS139009

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

Medline instant hot packs were activated upon arrival.These devices are to be activated only when ready for use.

• Brand Name: MEDLINE
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 12597803
• MDR Text Key: 275400688
• Report Number: 12597803
• 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: 09/30/2021

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: No Information
• Device Model Number: MDS139009
• Device Catalogue Number: MDS139009
• Device Lot Number: VN21141-4516
• 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: 09/30/2021
• Date Report to Manufacturer: 10/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1