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

Lot Number CN17203A2

Device Problem Material Rupture (1546)

Patient Problem Eye Injury (1845)

Event Date 04/06/2018

Event Type  Injury  

Event Description

When product squeezed, the bag ruptured injuring a patient's eye.

• Brand Name: MEDLINE DELUXE INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 7420945
• MDR Text Key: 105371673
• Report Number: MW5076402
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/09/2018

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 Lot Number: CN17203A2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR