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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. COTTON TIP WOODEN APPLICATOR
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MEDLINE INDUSTRIES, INC. COTTON TIP WOODEN APPLICATOR Back to Search Results
Catalog Number MDS202000
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/07/2014
Event Type  Injury  
Event Description
The tip broke off the applicator when inserted into a tunneled heel wound.
 
Manufacturer Narrative
The applicator tip broke off when it was inserted into a tunneled heel wound.A piece measuring approx 2.5 cam was retrieved from the wound.Attempts were made to gather add'l details but no other info was provided by the facility.No sample was returned for eval and a root cause has not been determined.A caution statement on the labeling indicates that this device should not be used in procedures which may require excessive pressure.It is possible that this may have been a contributing factor to the reported incident.
 
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Brand Name
COTTON TIP WOODEN APPLICATOR
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
mundelein IL 60060
Manufacturer Contact
julie finley
one medline place
mundelein, IL 60060
8476434709
MDR Report Key4001472
MDR Text Key4780693
Report Number1417592-2014-00070
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMDS202000
Device Lot Number506524393
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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