MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - LAREDO PACK OR BASIC ORTH PACK; ORTHOPEDIC TRAY

Model Number DYNJ49369

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

Medline basic orth tray had incorrect number of counted sponges in the tray.Four versus the five that are supposed to be present.Fda safety report id# (b)(4).

• Brand Name: PACK OR BASIC ORTH PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - LAREDO
• MDR Report Key: 12751721
• MDR Text Key: 280526239
• Report Number: MW5105136
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: DYNJ49369
• Device Catalogue Number: DYNJ49369
• Device Lot Number: 21FBM185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White