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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. STERILE HAND PACKS GENERAL SURGERY TRAY

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MEDLINE INDUSTRIES, INC. STERILE HAND PACKS GENERAL SURGERY TRAY Back to Search Results
Catalog Number DYNJ47243B
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 04/12/2018
Event Type  Malfunction  
Event Description

Medline hand packs and single towel packs contain lint. Two doctors wear magnification loops and it is clearly visible to the naked eye. Sterile hand packs: lot no. 18nb2483, ref no. Dynj47243b, exp. 10/31/2022. Sterile single pack towels: lot no. 26017090015, ref no. Mdt2168286. Manufacturer response for medline blue towels, (brand not provided) (per site reporter). A formal compliant was filed with medline. The company provided a postage paid return label requesting to send the product back to their company for investigation. Not willing or allowed to share address of manufacturer. Only country. Manufacturer response for sterile hand packs, (brand not provided) (per site reporter). A formal compliant was filed with medline. The company provided a postage paid return label requesting to send the product back to their company for investigation.

 
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Brand NameSTERILE HAND PACKS
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key7506169
MDR Text Key108008067
Report Number7506169
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2018
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberDYNJ47243B
Device LOT Number18NB2483
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/16/2018
Event Location Other
Date Report TO Manufacturer04/16/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/11/2018 Patient Sequence Number: 1
Treatment
AN ENTIRE OR SET UP; OTHER, FINDING REPORTED TO MEDLINE (BRIAN ARMSTR
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