MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-20 for VITAL SHIELD GOLD GLOVES * manufactured by Sgmp Co. Ltd.
[20912216]
A (b)(6) patient of dr (b)(6)- had an adverse reaction to a dental procedure. One of the items used in the procedure were vital shield gold gloves provided by my company. These are powered latex gloves. The lot number in question for the size 9. 0 gloves is 9197182-6923. No other reports of adverse reaction have been reported with either this lot number or any other lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017548 |
| MDR Report Key | 1843532 |
| Date Received | 2010-09-20 |
| Date of Report | 2010-09-20 |
| Date of Event | 2010-08-26 |
| Date Added to Maude | 2010-09-28 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SHIELD GOLD GLOVES |
| Generic Name | NON-STERILE MEDICAL EXAMINATION GLOVES SIZE 9 POWERED |
| Product Code | LYY |
| Date Received | 2010-09-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 9197182-6923 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SGMP CO. LTD |
| Manufacturer Address | 1800 MOO 6 TAMBON KAMPENGPHET AMPHUR RATTAPHUM SONGKHLA 90180 TH 90180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2010-09-20 |