MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-08-22 for ANCILLARY, HEADBAND UL PLUS BI AX1375BIF manufactured by Integra Burlington, Ma, Inc..
[4825025]
Customer initially reports a person using integra headlight suffered a burn to the head from the module melting when using our mlx light source. (b)(4) 2014, regional business manager for integra reported that the hospital risk manager informed him that there was no burn to anyone, no harm done. (b)(4) 2014 dealer confirms this is a melting module. (b)(4) 2014, although risk manager promised answers to email, none received yet. Number 2 of 3 devices reported.
Patient Sequence No: 1, Text Type: D, B5
[12301151]
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 | 1222895-2014-00021 |
| MDR Report Key | 4077355 |
| Report Source | 06,08 |
| Date Received | 2014-08-22 |
| Date of Report | 2014-07-29 |
| Date Mfgr Received | 2014-08-13 |
| Date Added to Maude | 2014-09-18 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCILLARY, HEADBAND UL PLUS BI |
| Generic Name | NA |
| Product Code | FSR |
| Date Received | 2014-08-22 |
| Catalog Number | AX1375BIF |
| 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 | 2014-08-22 |