MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN LAVH PACK; GYNECOLOGICAL LAPAROSCOPIC KIT

Model Number DYNJ49353

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

Medline lavh pack only had 9 of the 10 counted 4x4's in the pack.Fda safety report id# (b)(4).

• Brand Name: LAVH PACK
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN ; northfield IL 60093
• MDR Report Key: 11243513
• MDR Text Key: 229837782
• Report Number: MW5099057
• Device Sequence Number: 1
• Product Code: OHD
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: DYNJ49353
• Device Catalogue Number: DYNJ49353
• Device Lot Number: 20FBS121
• 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: 72 YR