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

Model Number DYNP2001S

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/29/2020

Event Type  malfunction  

Event Description

During donning of sterile surgical gown, as staff member pulled sleeve back following the application of sterile gloves, the gown material ripped.The gown material is very thin.Fda safety report id # (b)(4).

• Brand Name: SIRUS SURGICAL GOWN
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 10372876
• MDR Text Key: 202063609
• Report Number: MW5095908
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNP2001S
• Device Catalogue Number: DYNP2001S
• Device Lot Number: 72520030007
• 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