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

Lot Number 69719120002

Device Problem Explosion (4006)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

Coldpacks are from medline explode open when shaking to activate lot 69719120002.

• Brand Name: MEDLINE COLDPACKS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10448711
• MDR Text Key: 204421814
• Report Number: MW5096246
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/21/2020

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 Lot Number: 69719120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1