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 112-4992 manufactured by Oon Corp Resources.
[1747102]
The office alleges four staff members experienced eye irritation and a rash on their hands as follows: patient experienced eye irritation. None of the staff members required any medical attention other than the one staff member who had her eyes irrigated with the saline solution.
Patient Sequence No: 1, Text Type: D, B5
[6376202]
The office alleges four staff members experienced eye irritation and a rash on their hands as follows: patient experienced hand and eye irritation. None of the staff members required any medical attention other than the one staff member who had her eyes irrigated with the saline solution.
Patient Sequence No: 2, Text Type: D, B5
[6320005]
The office alleges four staff members experienced eye irritation and a rash on their hands as follows: patient experienced hand and eye irritation. None of the staff members required any medical attention other than the one staff member who had her eyes irrigated with the saline solution.
Patient Sequence No: 3, Text Type: D, B5
[6342738]
The office alleges four staff members experienced eye irritation and a rash on their hands as follows: patient experienced a rash on her hand and eye irritation which required her eyes to be irrigated with saline and lubricating drops. She also had swollen eyes. None of the staff members required any medical attention other than the one staff member who had her eyes irrigated with the saline solution.
Patient Sequence No: 4, Text Type: D, B5
| Report Number | 2411236-2010-00008 |
| MDR Report Key | 1927761 |
| 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 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 | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLUSION GLOVE STRAWBERRY |
| Generic Name | LATEX EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2010-12-07 |
| Returned To Mfg | 2010-11-18 |
| Catalog Number | 112-4992 |
| Lot Number | 666070 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OON CORP RESOURCES |
| Manufacturer Address | KHUSUS MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-07 |
| 2 | 0 | 2010-12-07 | |
| 3 | 0 | 2010-12-07 | |
| 4 | 0 | 2010-12-07 |