MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-12-02 for ILLUSION GLOVE STRAWBERRY 112-4992 manufactured by Oon Corp Resources.
[1684133]
The office alleges seven to eight staff members between the ages of (b)(6) experienced a reaction and a burning sensation on their hands that lasted a few days after using latex examination gloves. One person developed a sore and was administered cortisone cream; however, the other staff members did not seek any medical attention.
Patient Sequence No: 1, Text Type: D, B5
[8809574]
Additional info: lot# 666070.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411236-2010-00006 |
| MDR Report Key | 1938738 |
| Report Source | 99 |
| Date Received | 2010-12-02 |
| Date of Report | 2010-11-04 |
| Date of Event | 2010-11-04 |
| Date Facility Aware | 2010-11-04 |
| Report Date | 2010-12-02 |
| Date Reported to FDA | 2010-12-02 |
| Date Reported to Mfgr | 2010-12-02 |
| 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 |
| Brand Name | ILLUSION GLOVE STRAWBERRY |
| Generic Name | LATEX EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2010-12-02 |
| Returned To Mfg | 2010-11-29 |
| Catalog Number | 112-4992 |
| Lot Number | 670070 |
| 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. Required No Informationntervention | 2010-12-02 |