MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; EYE PACK

Catalog Number LYN023EPMEA

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Corneal Abrasion (1789)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the adhesive on the drape was too thick and the doctor caused corneal abrasions.It is unknown what part the drape played in this incident.There was no serious injury or additional intervention indicated.We were provided very limited information.It is not known if there were any underlying factors that may have played a role in this incident.We received an unused sample which was evaluated and found to be within specifications.We have no other complaints for this issue.Due to the reported incident and in an abundance of caution, this medwatch is being filed.

Event Description

It was reported that the adhesive on the drape has caused corneal abrasions.

• Type of Device: EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5609239
• MDR Text Key: 43684795
• Report Number: 1423395-2016-00034
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LYN023EPMEA
• Device Lot Number: 15XB8938
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other