MAUDE Adverse Event Report: MEDLINE MEDLINE SIRUS SURGICAL GOWN

Catalog Number	DYN20025
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: SURGICAL GOWN
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 7424952
• Report Number: MW5076447
• Device Sequence Number: 11301773
• Product Code: FYA
• UDI-Device Identifier: 10080196304677
• UDI-Public: 0110080196304677
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/10/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYN20025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1