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

Model Number DYNJ04557R

Device Problem Packaging Problem (3007)

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

Event Date 10/10/2019

Event Type  malfunction  

Event Description

Toe/finger nail found in lap sponge of laminectomy pack-pack b.In order to ready new set of supplies, two hour delay in surgery start time.

• Brand Name: LAMINECTOMY PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 9314594
• MDR Text Key: 166199197
• Report Number: 9314594
• 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: 10/30/2019,10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ04557R
• Device Catalogue Number: DYNJ04557R
• Device Lot Number: 19HKB745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2019
• Date Report to Manufacturer: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1