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

Catalog Number MDS202095

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/09/2014

Event Type  Injury  

Event Description

The cotton tip fell off the applicator and was not retrieved.

Manufacturer Narrative

Following abdominal surgery for colon cancer, the patient developed cellulitis of her incision.She cleaned the open surgical would twice daily with betadine and a cotton tip applicator.She reported the cotton tip came of the applicator and fell into the wound.The cotton tip was not retrieved.The patient was seen by her physician following the incident.The physician did not locate the cotton tip.She followed up with him again on (b)(6).He examined her again and was not able to locate the cotton tip or confirm its presence in the surgical wound.The sample was not returned for evaluation.We have not confirmed the issue or identified the root cause.However, in an abundance of caution, this medwatch is being filed.

• Brand Name: PLASTIC COTTON TIP APPLICATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4036281
• MDR Text Key: 4843277
• Report Number: 1417592-2014-00078
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDS202095
• Device Lot Number: 506794406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Patient Age: 68 YR