XTRA TRACTION SHOE COVER 69252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-04-25 for XTRA TRACTION SHOE COVER 69252 manufactured by Kimberly-clark Corp.

Event Text Entries

[230836] A curved sewing needle was inside the shoe cover and a boy put their foot inside the cover and stepped on the needle. The needle went through their foot. The boy rec'd a puncture wound and a tetanus shot was administered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8044184-2002-00001
• MDR Report Key: 390444
• Report Source: 06
• Date Received: 2002-04-25
• Date of Report: 2002-04-25
• Date of Event: 2002-04-05
• Date Mfgr Received: 2002-04-09
• Device Manufacturer Date: 2002-01-01
• Date Added to Maude: 2002-04-30
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 1400 HOLCOMB BRIDGE ROAD
• 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
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: XTRA TRACTION SHOE COVER
• Generic Name: SHOE COVER
• Product Code: FXP
• Date Received: 2002-04-25
• Model Number: NA
• Catalog Number: 69252
• Lot Number: 0042F02
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 379493
• Manufacturer: KIMBERLY-CLARK CORP
• Manufacturer Address: 1400 HOLMCOMB BRIDGE ROAD ROSWELL GA 30076 US
• Baseline Brand Name: XTRA TRACTION SHOE COVER
• Baseline Generic Name: SHOE COVER
• Baseline Model No: NA
• Baseline Catalog No: 69252
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2002-04-25