MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; COTTON TIPPED APPLICATOR, 375/PK, CVS PL

Catalog Number CVS165902

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

According to the customer in (b)(6) 2021, the cotton swab broke off in the customer's ear and had to have a doctor remove it.The sample is not available to be returned 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

According to the customer in (b)(6) 2021, the cotton swab broke off in the customer's ear and had to have a doctor remove it.

• Type of Device: COTTON TIPPED APPLICATOR, 375/PK, CVS PL
• 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: 15351597
• MDR Text Key: 299203649
• Report Number: 1417592-2022-00152
• 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: 09/02/2022

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: CVS165902
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male