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

Catalog Number 21295054

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, the cotton tip fell off in the ear canal.It was reported that the patient required sedation to remove the piece.A sample was requested to be returned for evaluation.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.

Event Description

Cotton tip fell off in ear canal.

• Type of Device: APPLICATOR, COTTON-TIP, WOOD, 6", NS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17088374
• MDR Text Key: 316853867
• Report Number: 1417592-2023-00243
• 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: 06/08/2023

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 Catalogue Number: 21295054
• Device Lot Number: 30122020002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/08/2023
• 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