MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-07 for VENOSCOPE manufactured by .
[61724384]
Received package of two nt01 neonatal transilluminators from (b)(6), biomed, on 10/20/2016 stating that he had a complaint that one of the two lights had caused a burn, but the staff was not sure which one. Mr. (b)(6) stated that he had seen the baby when he picked up the lights and the "burn" appeared to be minor showing a small reddish area. Both units were tested, using time/temp method, and were found to be well within the safe range when used according to the caution label which states that "do not leave light on baby's skin for an extended period of time (4 minutes or more). Check frequently for any heat buildup due to extended use". The unit was "on skin off/on for 2 minute period" which, according to tests, would not have generated sufficient heat to harm the baby. They did not state how many 2 minute periods it was used or how long the light was allowed to cool between uses. Returned both lights to (b)(6), biomed, along with the time/temp studies and a complaint disposition form.
Patient Sequence No: 1, Text Type: N, H10
[61724385]
See user facility description of event previously submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2319429-2016-00001 |
| MDR Report Key | 6152554 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-07 |
| Date Mfgr Received | 2016-10-31 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2016-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK CREAGHAN |
| Manufacturer Street | 1018 HARDING ST. SUITE 104 |
| Manufacturer City | LAFAYETTE LA 70503 |
| Manufacturer Country | US |
| Manufacturer Postal | 70503 |
| Manufacturer Phone | 8002847655 |
| Manufacturer G1 | VENOSCOPE, LLC |
| Manufacturer Street | 1018 HARDING ST. SUITE 104 |
| Manufacturer City | LAFAYETTE LA 70503 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 70503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENOSCOPE |
| Generic Name | NEONATAL TRANSILLUMINATOR |
| Product Code | HJN |
| Date Received | 2016-12-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-07 |