MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; APPLICATOR,COTTON-TIP,WOOD,6,NS

Catalog Number MWI601020

Device Problems Entrapment of Device (1212); Material Separation (1562); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the tip fell off in the dog's ear canal and the dog had to be sedated to retrieve it.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No sample was returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the tip fell off inside the canine's ear canal and the dog had to be sedated to be manually retrieved.

• Type of Device: APPLICATOR,COTTON-TIP,WOOD,6,NS
• 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: 12869288
• MDR Text Key: 281272167
• Report Number: 1417592-2021-00213
• 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: 11/24/2021

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 Catalogue Number: MWI601020
• Device Lot Number: 30120120015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/24/2021
• 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