MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for FREEGUARD RADIATION SURGICAL GLOVES RR1 BLACK LEAD FREE SURGICAL GLOVE manufactured by Emerson & Co., S. R. L..
[146265256]
Product contains lead. Labeling indicates no lead. The info note indicates no lead. Labeling does not match the ifu for labeling claims of no lead. Https://www. Bar-ray. Com/products/gloves/1036/sterile-radiation-reducing-gloves. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086898 |
| MDR Report Key | 8640728 |
| Date Received | 2019-05-23 |
| Date Added to Maude | 2019-05-24 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREEGUARD RADIATION SURGICAL GLOVES |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-05-23 |
| Model Number | RR1 |
| Catalog Number | BLACK LEAD FREE SURGICAL GLOVE |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMERSON & CO., S. R. L. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |