MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-19 for LIGHT SOURCE manufactured by .
[15656963]
In brief a headlamp was used to transilluminate an infants hand and this lead to bilateral palm blisters on the infant. Medical ctr uses a large number of luxtex products so it was assumed by the user that a luxtec headlamp was used. We contacted caren spagnuolo at med ctr to gain additional details on which luxtec product was used and caren let us know that she was not sure which product was used. If a luxtec headlamp was used it was used outside its indications for use. No luxtec products are indicated for use for transillumination.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221336-2008-00004 |
| MDR Report Key | 1275963 |
| Date Received | 2008-12-19 |
| Date Added to Maude | 2009-01-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LIGHT SOURCE |
| Product Code | HBI |
| Date Received | 2008-12-19 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-19 |