MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-02 for VENOSCOPE II manufactured by Venoscope.
[59039896]
Transilluminator was used to identify suitable vein in left upper arm for iv placement for tpn infusion-device on skin off/on for 2 minute period. Area of skin was noted to be warm to the touch and hard when the transilluminator was removed from the arm - left arm blister area of injury: 1. 5 cm x 7 cm. Mepilex dressing to site; removed on (b)(6) 2016 and left open to air. Site scabbed over as of (b)(6) 2016. We have 2 devices. Do not know which device was used. Device a and device b. Age of device: device 1 - 6 years; device 2 - 8 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6072216 |
| MDR Report Key | 6072216 |
| Date Received | 2016-11-02 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-10-13 |
| Date Facility Aware | 2016-10-13 |
| Date Reported to FDA | 2016-10-31 |
| Date Reported to Mfgr | 2016-10-31 |
| Date Added to Maude | 2016-11-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | VENOSCOPE II |
| Generic Name | TRANSILLUMINATOR |
| Product Code | HJM |
| Date Received | 2016-11-02 |
| Returned To Mfg | 2016-10-21 |
| Model Number | VENOSCOPE II |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENOSCOPE |
| Manufacturer Address | LAFAYETTE LA US |
| Brand Name | VENOSCOPE II |
| Generic Name | TRANSILLUMINATOR |
| Product Code | HJM |
| Date Received | 2016-11-02 |
| Returned To Mfg | 2016-10-21 |
| Model Number | VENOSCOPE II |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | VENOSCOPE |
| Manufacturer Address | LAFAYETTE LA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-02 |