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

Catalog Number CMPJ37657F

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/02/2020

Event Type  malfunction  

Event Description

Medline gown from a general laparoscopy pack had multiple holes in the sleeve.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: 9610651
• MDR Text Key: 175917512
• Report Number: MW5092351
• Device Sequence Number: 1
• Product Code: FYA
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CMPJ37657F
• Device Lot Number: 19HBW489
• 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