ILLUSION GLOVE STRAWBERRY 112-4993

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-12-07 for ILLUSION GLOVE STRAWBERRY 112-4993 manufactured by Oon Corp Resources.

Event Text Entries

[1826065] The office alleges two staff members experienced irritation from the gloves as follows: patient experienced eye irritation. None of the staff members required any medical attention.
Patient Sequence No: 1, Text Type: D, B5

[6321372] The office alleges two staff members experienced irritation from the gloves as follows: patient experienced a rash on her hands and eye irritation. None of the staff members required any medical attention.
Patient Sequence No: 2, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2411236-2010-00009
• MDR Report Key: 1927762
• Report Source: 99
• Date Received: 2010-12-07
• Date of Report: 2010-11-08
• Date of Event: 2010-11-08
• Date Facility Aware: 2010-11-08
• Report Date: 2010-12-07
• Date Reported to FDA: 2010-12-07
• Date Reported to Mfgr: 2010-12-07
• Date Added to Maude: 2011-11-02
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ILLUSION GLOVE STRAWBERRY
• Generic Name: LATEX EXAMINATION GLOVE
• Product Code: LYY
• Date Received: 2010-12-07
• Catalog Number: 112-4993
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OON CORP RESOURCES
• Manufacturer Address: KHUSUS MY

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-12-07
2	0		2010-12-07