MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE PELVIC EXAM TRAY; PELVIC EXAM KIT

Model Number	DYNE1045
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor used disposable pelvic kit to do vaginal exam.Has to open 3 kits because the speculum was defective - no lights.Fda safety report id# (b)(4).

• Brand Name: MEDLINE PELVIC EXAM TRAY
• Common Device Name: PELVIC EXAM KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC. ; northfield IL 60093
• MDR Report Key: 9244632
• Report Number: MW5090678
• Device Sequence Number: 19423771
• Product Code: MLT
• UDI-Device Identifier: 10884389479704
• UDI-Public: (01)10884389479704(10)201811
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: DYNE1045
• Device Catalogue Number: DYNDE1045
• Device Lot Number: 2018112090
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1