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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN LOU MAJOR PROCEDURE PACK GENERAL SURGERY TRAY

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MEDLINE INDUSTRIES - MUNDELEIN LOU MAJOR PROCEDURE PACK GENERAL SURGERY TRAY Back to Search Results
Catalog Number CMPJ05335G
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2020
Event Type  Malfunction  
Event Description

Opened lou major procedure pack for procedure. Scrub tech pulled back paper from foam component of needle book to adhere it to his mayo and discovered what appeared to be a dead insect adhered to the sticky side of the foam. Fda safety report id # (b)(4).

 
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Brand NameLOU MAJOR PROCEDURE PACK
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES - MUNDELEIN
MDR Report Key10816475
MDR Text Key216192055
Report NumberMW5097760
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCMPJ05335G
Device LOT Number20DBR165
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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