MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-16 for VEINLITE manufactured by Translite Llc.
[2596987]
Upon assessment of the pt, rn noted several incomplete red circular marks over a previous iv attempt sites. Two on his right inner lower forearm. One on his inner lower right forearm and two on his lower right inner ankle. The shape is consistent with the veinlite used during the iv attempts. No treatments were needed. Areas were left open to air.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024703 |
| MDR Report Key | 2500944 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-03-16 |
| Date of Event | 2012-03-15 |
| Date Added to Maude | 2012-03-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEINLITE |
| Generic Name | VEIN LOCATOR |
| Product Code | KYT |
| Date Received | 2012-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSLITE LLC |
| Manufacturer Address | 8410 HIGHWAY 50A SURGARLAND TX 77478 US 77478 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-16 |