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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. COTTON TIP APPLICATOR
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MEDLINE INDUSTRIES, INC. COTTON TIP APPLICATOR Back to Search Results
Catalog Number MDS202000
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 10/22/2013
Event Type  Injury  
Event Description
The cotton tip came off of the applicator during a surgical procedure.The tip was retrieved from the surgical site.
 
Manufacturer Narrative
During a laparoscopic appendectomy, the surgeon inserted the cotton tip applicator into the trochar to clean the opening.The cotton came off the tip and was retrieved from the surgical site.There was no injury or need for further intervention.The sample was discarded by the facility and not available for evaluation.We have no photo or lot number of the device involved in the incident.A root cause has not been determined.We have had no other similar incidents reported to us for this device in the past year.
 
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Brand Name
COTTON TIP APPLICATOR
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
mundelein IL
Manufacturer Contact
julie finley
one medline place
mundelein, IL 60060
8476434709
MDR Report Key3652955
MDR Text Key4318389
Report Number1417592-2014-00012
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 Health Professional,User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMDS202000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received01/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
Patient Age47 YR
Patient Weight57
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