MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-10 for LED HEADLIGHT W/ BATTERIES &AC/DC POWER SUPPLY -US 90520US manufactured by Integra Burlington, Ma, Inc..
[5463548]
Customer initially reports electric burn smell and cannot turn led off; (b)(6) 2015 customer reports event occurred during routine biomedical inspection, no harm done.
Patient Sequence No: 1, Text Type: D, B5
[13010811]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2015-00006 |
| MDR Report Key | 4594723 |
| Report Source | 06 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-13 |
| Date Mfgr Received | 2015-02-25 |
| Date Added to Maude | 2015-04-14 |
| 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 DR |
| 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 | 2015-03-10 |
| 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 | 2015-03-10 |