MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC MEDLINE GOWN EXAMINATION ; GENERAL SURGERY SCOPE PACK LF

Catalog Number	DYNJ0362388J
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
General surgery scope pack had a hole in the gown wrapper.Another one had to be opened and used.

• Brand Name: MEDLINE GOWN EXAMINATION
• Common Device Name: GENERAL SURGERY SCOPE PACK LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; northfield IL 60093
• MDR Report Key: 6522237
• Report Number: MW5069349
• Device Sequence Number: 13770344
• Product Code: FYA
• UDI-Device Identifier: 10889942059355
• UDI-Public: (01)10889942059355
• Initial Reporter State: CO
• 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): 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: DYNJ0362388J
• Device Lot Number: 17AK1759
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1