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 112-4991 manufactured by Oon Corp Resources.
[1764465]
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
[8806917]
Additional lot #: 510070.
Patient Sequence No: 1, Text Type: N, H10
[6376203]
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
| Report Number | 2411236-2010-00007 |
| MDR Report Key | 1927844 |
| 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 |
| 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 | 112-4991 |
| Lot Number | 509070 |
| 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 | 2010-12-07 | |
| 2 | 0 | 2010-12-07 |