MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. / MEDLINE INDUSTRIES, LP - LAREDO BASIC ORTHO TRAY; ORTHOPEDIC TRAY

Model Number DYNJ49369

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Long black hair found in medline basic ortho tray from the manufacturer.Fda safety report id# (b)(4).

• Brand Name: BASIC ORTHO TRAY
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC. / MEDLINE INDUSTRIES, LP - LAREDO; northfield IL 60093
• MDR Report Key: 14021412
• MDR Text Key: 288818976
• Report Number: MW5108778
• Device Sequence Number: 1
• Product Code: OJH
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: DYNJ49369
• Device Catalogue Number: DYNJ49369
• Device Lot Number: 22ABB739
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White