MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE SURGICAL GOWN; GOWN, SURGICAL

Lot Number DYNJP2402

Device Problem Product Quality Problem (1506)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/26/2019

Event Type  malfunction  

Event Description

Surgeon removed gown at end of case and noted blood on his arm and pants.Upon evaluation of where it came from, the gown was shown to have blood on the anterior of the gown that had leaked through during the case.Gown is new gown from medline conversion - dynjp2402.Dir of both operating room and supply chain notified of concern.Fda safety report id# (b)(4).

• Brand Name: MEDLINE SURGICAL GOWN
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 8960086
• MDR Text Key: 156558965
• Report Number: MW5089510
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: DYNJP2402
• Was Device Available for Evaluation?: No
• 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