MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CTA, PLASTIC, 500CT, 24/CS

Catalog Number WRX340917

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2022

Event Type  Injury  

Event Description

According to the customer, when using the cotton tips the cotton 'fell off inside of her ear'.According to the customer, a pair of 'tweezers' was required to remove the cotton from 'her ear'.

Manufacturer Narrative

According to the customer, when using the cotton tips the cotton 'fell off inside of her'.According to the customer, a pair of 'tweezers' was required to remove the cotton from 'her ear'.The customer reported no medical intervention or serious injury occurred related to this event.Sample requested to be returned.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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: CTA, PLASTIC, 500CT, 24/CS
• 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: 16087346
• MDR Text Key: 306537301
• Report Number: 1417592-2023-00004
• 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: 01/03/2023

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: Other
• Device Catalogue Number: WRX340917
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/03/2023
• 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