FDA Adverse Event Injury Summary report: N

APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE

MDR report key: 20351823 · Received October 2, 2024

Report

Report Number
1417592-2024-00877
Event Type
Injury
Date Received
October 2, 2024
Date of Event
August 19, 2024
Report Date
October 2, 2024
Manufacturer
MEDLINE INDUSTRIES LP
Product Code
KXG
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
AR, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 0

ACCORDING TO THE FACILITY ON (B)(6), "WHEN THE PHYSICIAN WAS USING A COTTON-TIPPED APPLICATOR TO PROBE THE BASE OF A WOUND, WHEN REMOVING THE APPLICATOR, THE COTTON TIP FELL OFF INTO THE WOUND BED. THIS PIECE HAD TO BE REMOVED WITH FORCEPS. THERE WAS NO IMPACT TO THE PATIENT". A SAMPLE IS NOT AVAILABLE FOR EVALUATION. 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.

Description of Event or Problem · 0

ACCORDING TO THE FACILITY ON (B)(6), "WHEN THE PHYSICIAN WAS USING A COTTON-TIPPED APPLICATOR TO PROBE THE BASE OF A WOUND, WHEN REMOVING THE APPLICATOR, THE COTTON TIP FELL OFF INTO THE WOUND BED.".

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1948719 APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE KXG MEDLINE INDUSTRIES LP 39523120002

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other