AMERINET SHOE COVER W/EXTRA TRACTION, XL
Received Aug 5, 2005 · Event occurred Jun 5, 2005
Report 1033422-2005-00049 · MDR key 624493
Device
Generic name
Shoe Cover
Manufacturer
Kimberly-clark Corp.Model number
NACatalog number
69161
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Fall
- Injury
- Surgical procedure
Narrative
Description of Event or Problem
"THE SHOE COVER WAS DETERMINED A CAUSE IN A FALL THAT HAPPENED 2 MONTH AGO". (THE EVENT DATE PROVIDED IS AN ESTIMATED DATA BASED ON 60 DAYS PRIOR TO THE MDR REPORT DATE). A HOSP SAFETY COMMITTEE'S INVESTIGATION FOUND THAT THE NURSE SUSTAINED A FACIAL INJURY AFTER HITTING THEIR HEAD IN THE FALL AND REQUIRED STITCHES. THEY ARE IN THE FALL AND REQUIRED STITCHES. THEY ARE BACK AT WORK NOW. THE HOSP DID NOT HAVE THE LOT NUMBER NOT THE DATE OF THE FALL. KIMBERLY-CLARK CORPORATION HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING INFORMATION RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.