MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; ORTHOPEDIC TRAY

Model Number DYNJ04557R

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 06/07/2019

Event Type  malfunction  

Event Description

Hair found on lap sponge in laminectomy pack.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9543056
• MDR Text Key: 173461759
• Report Number: 9543056
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ04557R
• Device Catalogue Number: DYNJ04557R
• Device Lot Number: 19GKB556
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2019
• Date Report to Manufacturer: 01/03/2020
• Type of Device Usage: N
• Patient Sequence Number: 1