MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. / MEDLINE INDUSTRIES, LP - MEXICALI (MXC) BASIC ORTHO TRAY O.R. ORTHO PACK; ORTHOPEDIC TRAY

Model Number DYNJ49369

Device Problem Component Missing (2306)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

Only 4 of 5 - 12x12 x-ray lap sponges were included in our basic ortho tray.Fda safety report id# (b)(4).

• Brand Name: BASIC ORTHO TRAY O.R. ORTHO PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC. / MEDLINE INDUSTRIES, LP - MEXICALI (MXC); northfield IL 60093
• MDR Report Key: 14282617
• MDR Text Key: 290801886
• Report Number: MW5109498
• 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: 04/29/2022

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: 10/31/2023
• Device Model Number: DYNJ49369
• Device Catalogue Number: DYNJ49369
• Device Lot Number: 22ABB739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White