MAUDE Adverse Event Report: MEDLINE INDUSTRIES MEDLINE - SURGICAL GOWN LEVEL 3; SIRUS SURGICAL GOWN

Model Number DYNJP2001S

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/09/2019

Event Type  malfunction  

Event Description

Hair found in sterile pack of large surgical gown manufactured by medline.The gown was not used in the procedure.We have the gown.Date of manufacture: 12/15/2018.Gown opened for a surgical procedure and a hair was noted.Gown was removed from the room, reported to risk and quality.

• Brand Name: MEDLINE - SURGICAL GOWN LEVEL 3
• Type of Device: SIRUS SURGICAL GOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• MDR Report Key: 8536073
• MDR Text Key: 142879993
• Report Number: MW5086036
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJP2001S
• Device Catalogue Number: 0110080196304460
• Device Lot Number: (10)72518120009
• 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