MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-12 for OHMEDA PHOTOTHERAPY LIGHT 6600-0287-904 NA manufactured by Burton Medical Products.
[484516]
Bulb of phototherapy light burst while in use. A few gragments of the bulb fell next to the pt. Pt was not affected by fragments and no injuries occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018492-2006-00008 |
| MDR Report Key | 714589 |
| Report Source | 06 |
| Date Received | 2006-05-12 |
| Date of Report | 2006-05-12 |
| Date of Event | 2006-04-12 |
| Date Mfgr Received | 2006-04-12 |
| Device Manufacturer Date | 1995-03-01 |
| Date Added to Maude | 2006-05-17 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHELSEA MITCHELL |
| Manufacturer Street | 21100 LASSEN AVE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8187018700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OHMEDA PHOTOTHERAPY LIGHT |
| Generic Name | PHOTOTHERAPY LIGHT |
| Product Code | KGL |
| Date Received | 2006-05-12 |
| Returned To Mfg | 2006-05-05 |
| Model Number | 6600-0287-904 |
| Catalog Number | NA |
| Lot Number | 0395 BURT |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 703654 |
| Manufacturer | BURTON MEDICAL PRODUCTS |
| Manufacturer Address | * CHATSWORTH CA * US |
| Baseline Brand Name | SPOT PHOTOTHERAPY FLOOR MOUNT LIGHT |
| Baseline Generic Name | FLOOR MOUNT |
| Baseline Model No | 6600-0287-904 |
| Baseline Catalog No | * |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-12 |