POWER-FREE SYNTHETIC VINYL EXAM GLOVES 14-116 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-19 for POWER-FREE SYNTHETIC VINYL EXAM GLOVES 14-116 * manufactured by Mckesson Medi-pak.

Event Text Entries

[19541627] Vinyl gloves used in clinic as iniversal precautions barrier. Gloves have random holes and tears in them. The gloves tear easily when applying. Two boxes of gloves were examined with same lot #, with the same results.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1037735
• MDR Report Key: 667815
• Date Received: 2006-01-19
• Date of Report: 2005-12-30
• Date of Event: 2005-12-19
• Date Added to Maude: 2006-01-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: POWER-FREE SYNTHETIC VINYL EXAM GLOVES
• Generic Name: POWER-FREE SYNTHETIC VINYL EXAM GLOVES
• Product Code: LYZ
• Date Received: 2006-01-19
• Model Number: 14-116
• Catalog Number: *
• Lot Number: CZE07-16
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 657172
• Manufacturer: MCKESSON MEDI-PAK
• Manufacturer Address: * RICHMOND VA * US

Device Sequence Number: 2

• Brand Name: POWER-FREE SYNTHETIC EXAM GROVE
• Generic Name: MCKESSON
• Product Code: LYZ
• Date Received: 2006-01-19
• Model Number: 14-116
• Catalog Number: *
• Lot Number: CZE07-16
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 657175
• Manufacturer: MCKESSON MEDI-PAK
• Manufacturer Address: * RICHMOND VA 23228 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-01-19