MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-19 for LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US 90520US manufactured by Integra Burlington, Ma, Inc.
[5505242]
Customer initially reports that he had an led unit that was no longer working. The unit's back switch where you can adjust intensity does not allow the light to be turned off. Also, the operating room reported a funny small coming from the unit when turned on. A smoky smell like something was burning (b)(6) 2015 no harm done, no further information available.
Patient Sequence No: 1, Text Type: D, B5
[12843316]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2015-00005 |
| MDR Report Key | 4535955 |
| Report Source | 06 |
| Date Received | 2015-02-19 |
| Date of Report | 2015-01-27 |
| Date of Event | 2015-01-27 |
| Date Mfgr Received | 2015-01-27 |
| Date Added to Maude | 2015-03-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2015-02-19 |
| Catalog Number | 90520US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA, INC |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-19 |