MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP COTTON TIPPED APPLICATOR

Catalog Number CVS306091

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer they were using the cotton swab to clean their ear canal and a portion of the swab broke off and has been stuck in their ear canal for weeks'.Per the customer they are still able to feel the piece of the swab in their ear canal and have not attempted to remove it as they were hoping the piece would fall out on its own.Per the customer they will be going to their primary care physician to determine next steps for removal.The sample has not been returned to the manufacturer for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the customer was using the cotton swab to clean their ear canal and a portion of the swab broke off into their ear canal.

• Brand Name: COTTON TIPPED APPLICATOR
• Type of Device: COTTON TIPPED APPLICATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15135533
• MDR Text Key: 296943046
• Report Number: 1417592-2022-00121
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: CVS306091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/29/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female