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

Model Number DYNJP2307P

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Event Description

When opening a sterile surgical gown, a wooden stick was found in the packaging; before it was opened onto the sterile field.No patient harm.No delay to procedure.

• Brand Name: MEDLINE
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7536829
• MDR Text Key: 109021727
• Report Number: 7536829
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10080196290765
• UDI-Public: 0110080196290765
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DYNJP2307P
• Device Catalogue Number: DYNJP2307P
• Device Lot Number: (10)72517120081
• Other Device ID Number: (11)171210 (10)72517120081
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.