MAUDE Adverse Event Report: MEDLINE MEDLINE SIRUS SURGICAL GOWN

Catalog Number DYN20025

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 04/09/2018

Event Type  malfunction  

Event Description

Provider scrubbed in for a case wearing a medline sirus surgical gown level three and twice the gowns ripped at the same place with little pressure applied while putting on gloves.The reference number is (b)(4) and the bar code number is (b)(4).

• Brand Name: MEDLINE SIRUS SURGICAL GOWN
• Type of Device: SURGICAL GOWN
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 7424952
• MDR Text Key: 105451954
• Report Number: MW5076447
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10080196304677
• UDI-Public: 0110080196304677
• Combination Product (y/n): N
• 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: 04/10/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYN20025
• 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