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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE RENEWAL ARTHROSCOPE

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MEDLINE INDUSTRIES, INC. MEDLINE RENEWAL ARTHROSCOPE Back to Search Results
Model Number UM1882940HRR
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Insufficient Information (4580)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
After sterile instrument was opened, the scrub noticed a white, sticky substance on the turbinate shaver. As she pulled it out, she noticed it was melted on the inside of the turbinate shaver. She passed it off the field and asked for another one. Clinical staff opened 6 shavers that had the same problems. Clinical staff went to look for another one that was ordered and had just come in. It was opened and also had the same white, sticky substance on it. The doctor was able to use another size, the scrub changed her gloves. The surgeon was not to happy about the possible contamination.
 
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Brand NameMEDLINE RENEWAL
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
1 medline place
mundelein IL 60060
MDR Report Key12719187
MDR Text Key279034885
Report Number12719187
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUM1882940HRR
Device Catalogue NumberUM1882940HRR
Device Lot Number454016
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2021
Event Location Hospital
Date Report to Manufacturer10/29/2021
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? No
Type of Device Usage Unkown

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