MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. LOU MAJOR PROCEDURE LIGHT HANDLE COVERS; LIGHT, SURGICAL ACCESSORIES

Catalog Number DYNJ9009771

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/06/2019

Event Type  malfunction  

Event Description

Opened a major pack from medline and the light cover handles had slits in them.Opened an individual light handle and it had a pin hole in it.Fda safety report id# (b)(4).

• Brand Name: LOU MAJOR PROCEDURE LIGHT HANDLE COVERS
• Type of Device: LIGHT, SURGICAL ACCESSORIES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8703736
• MDR Text Key: 148295463
• Report Number: MW5087390
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2019

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 Expiration Date: 11/30/2020
• Device Catalogue Number: DYNJ9009771
• Device Lot Number: 19DBD799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2019
• 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