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

Lot Number 48818120001

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 08/15/2019

Event Type  malfunction  

Event Description

When activating the cold pack per manufacturer instructions, sides split open and leaked content.Manufacturer response for cold pack, medline (per site reporter): purchasing working with vendor.

• Brand Name: MEDLINE
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8964589
• MDR Text Key: 156627620
• Report Number: 8964589
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 48818120001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1