MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-COTTON TIPPED APPLICATOR, 600/PK, CV

Catalog Number CVS348747V3

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Skin Inflammation/ Irritation (4545)

Event Date 03/20/2023

Event Type  Injury  

Event Description

According to the customer, when pulling the cotton tip out of her ear she noticed that the "tip was missing" and her ear was "uncomfortable, irritated, and red".

Manufacturer Narrative

According to the customer, when pulling the cotton tip out of her ear she noticed that the "tip was missing" and her ear was "uncomfortable, irritated, and red".The customer reported they could not find the tip and went to "urgent care" where they were prescribed "neomycin drops".The customer reported after using the drops for "a few days" her ear is "feeling better".Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: DBD-COTTON TIPPED APPLICATOR, 600/PK, CV
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16727127
• MDR Text Key: 313160310
• Report Number: 1417592-2023-00163
• 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: 04/12/2023

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: CVS348747V3
• Device Lot Number: 348747
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/12/2023
• 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): Other