SHOE COVER, GRIPPER, NON-SKID * NON24758

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-02-11 for SHOE COVER, GRIPPER, NON-SKID * NON24758 manufactured by Medline Industries, Inc..

Event Text Entries

[173746] Reportedly, two nurses fell forward while wearing shoe covers. One nurse rec'd a sore knee, no medical treatment was required. The other nurse broke her jaw, nose and some teeth. The second nurse required to have her jaw wired and some dental surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1417592-1999-00006
• MDR Report Key: 209672
• Report Source: 05,06
• Date Received: 1999-02-11
• Date of Report: 1999-01-13
• Date of Event: 1998-11-25
• Date Facility Aware: 1999-01-13
• Report Date: 1999-02-11
• Date Reported to FDA: 1999-02-11
• Date Reported to Mfgr: 1999-02-11
• Date Added to Maude: 1999-02-16
• 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: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SHOE COVER, GRIPPER, NON-SKID
• Generic Name: SHOE COVER
• Product Code: BWP
• Date Received: 1999-02-11
• Model Number: *
• Catalog Number: NON24758
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 203484
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Manufacturer Address: ONE MEDLINE PL. MUNDELEIN IL 60060 US
• Baseline Brand Name: SHOE COVER, GRIPPER, NON-SKID
• Baseline Generic Name: SHOE COVER
• Baseline Model No: *
• Baseline Catalog No: NON24758
• Baseline ID: *
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-02-11