MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE CUSTOM GYN LAPAROSCOPY PACK; GENERAL SURGICAL TRAY

Catalog Number DYNJ60999

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/02/2020

Event Type  malfunction  

Event Description

Hole in drape inside of gyn laparoscopy custom pack.Fda safety report id# (b)(4).

• Brand Name: MEDLINE CUSTOM GYN LAPAROSCOPY PACK
• Type of Device: GENERAL SURGICAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL
• MDR Report Key: 9763986
• MDR Text Key: 181767427
• Report Number: MW5093343
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: DYNJ60999
• Device Lot Number: 19HBZ851
• 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