FDA Adverse Event Malfunction Summary report: N

READY CARE DENTASWAB

MDR report key: 1619843 · Received February 26, 2010

Report

Report Number: 8030647-2010-00002
Event Type: Malfunction
Date Received: February 26, 2010
Report Date: January 28, 2010
Manufacturer: AVENT S.A. DE R.L. DE C.V.
Product Code: KXF
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT NUMBER PROVIDED AND FOUND THAT ALL PRODUCT MET MANUFACTURER'S SPECIFICATIONS. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONDUCT A THOROUGH INVESTIGATION AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THIS COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE COMPLAINT IS CLOSED. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS AND CORRECTIVE ACTIONS WILL BE TAKEN.

Description of Event or Problem · 1

KIMBERLY CLARK RECEIVED A COMPLAINT INDICATING THAT WHILE REMOVING THE READY CARE DENTABSWAB, THE SWAB CAME OFF THE TIP AND WAS BREATHED INTO THE PATIENT'S NASAL PASSAGE. THE SWAB WAS REMOVED DURING A DOCTOR'S OFFICE VISIT. NO INJURY WAS REPORTED. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	READY CARE DENTASWAB	DISPOSABLE ORAL SWABS	KXF	AVENT S.A. DE R.L. DE C.V.		M9250A201

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention