MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-07-25 for * manufactured by Venoscope, Llc.
[7781134]
Clinical engineering called to say that the device had left a blister on the pt. It was not life threatening or permanent. He did not return the light for our eval, however, we examined one from the same batch and discovered that two wires on the pc board to the led were reversed. Although the light passed our quality check we discoverd that it would accumulate heat that was out of spec if it was left on for longer than usually necessary for the procedure. The instructions show a nurse holding the light in the palm of her hand so she would know if it overheated. I informed clinical engineer of the problem and requested that he return the light for replacement. He did not responsed, yet the hosp subsequently purchased more lights. We notified all the affected users of the potential problem if they left it on for an extended period of time and requested that they return them for replacement. We determined that this did not cause or contribute to cause death or serious injury and we handled it as a minor product error that was quickly and easily remedied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2319429-2006-00001 |
| MDR Report Key | 740929 |
| Report Source | 06 |
| Date Received | 2006-07-25 |
| Date of Report | 2005-05-04 |
| Date of Event | 2005-04-28 |
| Date Mfgr Received | 2005-04-28 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-07-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | FRANK CREAGHAN, JR |
| Manufacturer Street | 1018 HARDING ST STE 104 |
| Manufacturer City | LAFAYETTE LA 70503 |
| Manufacturer Country | US |
| Manufacturer Postal | 70503 |
| Manufacturer Phone | 3372348993 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | HJN |
| Date Received | 2006-07-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 728797 |
| Manufacturer | VENOSCOPE, LLC |
| Manufacturer Address | 1018 HARDING ST., SUITE 104 LAFAYETTE LA 70503 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-25 |