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

Model Number MDS137000

Device Problems Unintended Ejection (1234); Improper or Incorrect Procedure or Method (2017)

Patient Problem Itching Sensation (1943)

Event Date 12/02/2020

Event Type  malfunction  

Event Description

Description of issue: the patient reported that she felt itching.The ice pack was found out to be leaking on the long side of the package (not near a seam).Clinical staff immediately flushed the patients eye at an eyewash and notified the treating physicians on-call pager.A physician came to bedside and directed clinical staff to continue flushing the patients eye for 5-10 mins.The patients eye was flushed for the complete time.On follow-up thereafter, no effects were noted.Follow-up: on review with the staff member who used the ice pack, they had squeezed the packaging to open it.However, the use instructions indicate that it is to be folded over and shaken.There are also pictures on the front of the ice pack.Staff member was re-educated on use of the item and need to confirm packaging is intact before patient use.

• Brand Name: MEDLINE INSTANT COLD PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11139382
• MDR Text Key: 225754353
• Report Number: 11139382
• 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: 12/23/2020

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 Model Number: MDS137000
• Device Catalogue Number: MDS137000
• Device Lot Number: 69720070002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14235 DA
• Patient Weight: 66