MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GENERAL LAPAROSCOPY-LF GOWN; GOWN, SURGICAL

Catalog Number CMPJ37657F

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2020

Event Type  malfunction  

Event Description

General laparoscopy pack had a sterile gown with holes noted in the right arm of the impervious protection.Fda safety report id # (b)(4).

• Brand Name: GENERAL LAPAROSCOPY-LF GOWN
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; northfield IL 60093
• MDR Report Key: 11163211
• MDR Text Key: 227026026
• Report Number: MW5098785
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: CMPJ37657F
• Device Lot Number: 20GBE978
• 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