MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN PREMIUM DRY TRAY PREP TRAY; GENERAL SURGERY TRAY

Model Number DYND70661

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2020

Event Type  malfunction  

Event Description

Long black hair found in sterile, sealed medline "premium dry tray".Fda safety report id # (b)(4).

• Brand Name: PREMIUM DRY TRAY PREP TRAY
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN
• MDR Report Key: 10967299
• MDR Text Key: 220499646
• Report Number: MW5098246
• Device Sequence Number: 1
• Product Code: LRO
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND70661
• Device Catalogue Number: DYND70661
• Device Lot Number: 96919120001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 22 YR