SHOE COVER, GRIPPER, NON-SKID * NON27758

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 1999-05-12 for SHOE COVER, GRIPPER, NON-SKID * NON27758 manufactured by Medline Industries, Inc..

Event Text Entries

[16786852] Reportedly, personnel have slipped while wearing shoe covers in wet areas. No medical treatment was required.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1417592-1999-00014
• MDR Report Key: 223098
• Report Source: 05,06
• Date Received: 1999-05-12
• Date of Report: 1999-04-12
• Date Facility Aware: 1999-04-12
• Report Date: 1999-05-12
• Date Reported to FDA: 1999-05-12
• Date Reported to Mfgr: 1999-05-12
• Date Added to Maude: 1999-05-18
• 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: 1999-05-12
• Model Number: *
• Catalog Number: NON27758
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 216359
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Manufacturer Address: ONE MEDLINE PL. MUNDELEIN IL 60060 US
• Baseline Brand Name: SHOE COVER, GRIPPER, NON-SKID
• Baseline Model No: *
• Baseline Catalog No: NON27758
• 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	1999-05-12