MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-11-09 for LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US 90520US manufactured by Integra Burlington, Ma, Inc..
[2922255]
The customer initially reports the surgeon was in the middle of the case when he says the unit began to flicker. He then said he noticed it got hot on his head and he felt a burning sensation. On (b)(4) 2012, integra representative reports via email that the surgeon said the headlight got very hot on his head and smelled of burned plastic. He immediately turned the led to the off positon and took it off his head. The surgeon did not get burned but did sense the intensity of the heat to the point where he had concern.
Patient Sequence No: 1, Text Type: D, B5
[10267545]
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 | 1222895-2012-00036 |
| MDR Report Key | 2834881 |
| Report Source | 05,08 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-11-09 |
| Date Mfgr Received | 2012-11-01 |
| Date Added to Maude | 2013-02-19 |
| 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 | 2012-11-09 |
| Catalog Number | 90520US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-11-09 |