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

Model Number	DYNJP2307P
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7536829
• Report Number: 7536829
• Device Sequence Number: 2413301
• Product Code: FYA
• UDI-Device Identifier: 10080196290765
• UDI-Public: 0110080196290765
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018
• Report Date (Section F): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT APPLICABLE.
• Date Report Sent to FDA: 05/14/2018