X-TRA TRACTION SHOE COVER 69254

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2001-06-26 for X-TRA TRACTION SHOE COVER 69254 manufactured by Kimberly-clark Corp.

Event Text Entries

[16832696] An or nurse slipped and fell in the operating room while wearing shoe covers and had to receive stitches.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8044184-2001-00002
• MDR Report Key: 339867
• Report Source: 06,07
• Date Received: 2001-06-26
• Date of Report: 2001-06-25
• Date of Event: 2001-06-12
• Date Mfgr Received: 2001-06-15
• Date Added to Maude: 2001-07-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 1400 HOLCOMB BRIDGE RD
• Manufacturer City: ROSWELL GA 30076
• Manufacturer Country: US
• Manufacturer Postal: 30076
• Manufacturer Phone: 7705878279
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: X-TRA TRACTION SHOE COVER
• Generic Name: SHOE COVER
• Product Code: FXP
• Date Received: 2001-06-26
• Model Number: NA
• Catalog Number: 69254
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 329191
• Manufacturer: KIMBERLY-CLARK CORP
• Manufacturer Address: 1400 HOLCOMB BRIDGE RD ROSWELL GA 30076 US
• Baseline Brand Name: X-RA TRACTION SHOE COVER
• Baseline Generic Name: SHOE COVER
• Baseline Model No: NA
• Baseline Catalog No: 69254
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-06-26