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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES BLADE,CARBON-STEEL,#11,STRL,DISPOSABLE

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MEDLINE INDUSTRIES BLADE,CARBON-STEEL,#11,STRL,DISPOSABLE Back to Search Results
Catalog Number MDS15011
Device Problem Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
It was reported that a surgeon noticed discoloration on the scalpel blade after being used. The discoloration was not noticed on the blade before use and the blade was not visually inspected prior to use. The blade was used to make the initial incision and used within the surgical site. No harm came to the patient. The sample was received for evaluation and the issue was confirmed. Due to the reported incident and in an abundance of caution this medwatch is being filed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after the initial incision, the blade was noticed to be discolored.
 
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Type of DeviceBLADE,CARBON-STEEL,#11,STRL,DISPOSABLE
Manufacturer (Section D)
MEDLINE INDUSTRIES
three lakes drive
northfield IL 60093
Manufacturer (Section G)
MEDLINE INDUSTRIES
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
8476434960
MDR Report Key7072542
MDR Text Key93820651
Report Number1417592-2017-00077
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMDS15011
Device Lot Number102782
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/03/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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