MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; COTTON TIPPED APPLICATOR, 625/PK, CVS PL

Catalog Number CVS258430

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported by the end user that a cotton tip broke off in his ear and had to be removed in an emergency room.

Manufacturer Narrative

It was reported by the end user that a cotton tip broke off in his ear and had to be removed in an emergency room.No additional details are available related to the customer reported issue.The customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was not returned to the manufacturer 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.

• Type of Device: COTTON TIPPED APPLICATOR, 625/PK, CVS PL
• 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: 13549912
• MDR Text Key: 285805161
• Report Number: 1417592-2022-00012
• 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: 02/17/2022

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: CVS258430
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/17/2022
• 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