SHOE COVER 69111

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 2002-06-18 for SHOE COVER 69111 manufactured by *.

Event Text Entries

[21399123] A surgical tech slipped and fell, while wearing shoe covers, on a wet floor. Fall resulted in a dislocated shoulder. Tech has reported back to work.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1033422-2002-00002
• MDR Report Key: 400805
• Report Source: 06,07
• Date Received: 2002-06-18
• Date of Report: 2002-06-17
• Date of Event: 2002-06-13
• Date Mfgr Received: 2002-06-13
• Date Added to Maude: 2002-06-24
• 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
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SHOE COVER
• Generic Name: SHOE COVER
• Product Code: FXP
• Date Received: 2002-06-18
• Model Number: NA
• Catalog Number: 69111
• Lot Number: DD032302
• 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: 389855
• Manufacturer: *
• Manufacturer Address: * * *
• Baseline Brand Name: SHOE COVER
• Baseline Generic Name: SHOE COVER
• Baseline Model No: NA
• Baseline Catalog No: 69111
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2002-06-18