MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. COTTON TIP WOOD APPLICATOR

Catalog Number MDS202000

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/21/2014

Event Type  Injury  

Event Description

The cotton tip came off the applicator when measuring the depth of a wound.

Manufacturer Narrative

The cotton tip came off the applicator as the physician was measuring the depth of a wound with the applicator.The depth of the insertion is not known.The cotton was retrieve via surgical débridement without further incident.The issue was confirmed with the returned sample.A root cause has not been determined.

• Brand Name: COTTON TIP WOOD APPLICATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4278991
• MDR Text Key: 5034547
• Report Number: 1417592-2014-00105
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDS202000
• Device Lot Number: 506963984
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR