MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; COTTON TIPPED APPLICATOR, 300/PK, CVS

Catalog Number CVS306091

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2022 he was using a cotton swab to clean his ear.Per the customer he stuck the cotton swab in his ear canal and the cotton tip came off of the plastic stick portion of the swab.Per the customer he had to go to the emergency room to have a physician remove the cotton portion of the swab from his ear canal.Per the customer he is doing fine and does not have any lingering effects from the event.The sample is available but has not been returned for evaluation.No additional information is available.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

According to the customer he had to have a cotton tip removed from his ear canal at the emergency room.

• Type of Device: COTTON TIPPED APPLICATOR, 300/PK, CVS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14575985
• MDR Text Key: 293306341
• Report Number: 1417592-2022-00071
• 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
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CVS306091
• Device Lot Number: 31221050019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male