FDA Adverse Event Other Summary report: N

HI GUARD REGULAR FULL COVERAGE BOOT

MDR report key: 925268 · Received October 10, 2007

Report

Report Number: 3004713352-2007-00135
Event Type: Other
Date Received: October 10, 2007
Date of Event: September 14, 2007
Report Date: October 10, 2007
Manufacturer: LYG AIYEH NONWOVEN PRODUCTS CO., LTD.
Product Code: LYU
Removal / Correction Number: NA
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH THE COATING OF THE BOOT IS IMPERVIOUS, THE SEAMS ARE NOT. THEREFORE, THE BOOT COVERS AS A WHOLE ARE ONLY MEANT TO WITHSTAND SPLASHING, NOT EXCESSIVE AMOUNTS OF FLUID. THE BOOT COVERS ARE NOT MEANT TO BE USED IN SITUATIONS WHERE THE BOOT COVER WOULD BE SOAKED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT DURING A TWO HOUR ORTHO PROCEDURE WITH MUCH FLUID AT THE SHOULDER, THE SURGEON'S SHOES HAD BLOOD STRIKETHROUGH. THE STRIKETHROUGH WAS LOCATED AT THE BOTTOM OF THE SHOE COVER WHERE BLOOD WENT THROUGH THE SEAM. THE USER FACILITY WAS NOT PRECISE IF BLOOD REACHED THE DOCTOR'S SKIN AND IF THE DOCTOR'S SKIN WAS INTACT. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HI GUARD REGULAR FULL COVERAGE BOOT	ACCESSORIES, SURGICAL APPAREL	LYU	LYG AIYEH NONWOVEN PRODUCTS CO., LTD.	NA	CA7025003

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR