MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-03-19 for SP CE SAPH3 SS LIGHT PANEL 89-2718 manufactured by Genzyme Biosurgery A Division Of Genzyme.
[253836]
The customer alleged that while using the saphlite system, the light panel began to smoke while in the leg incision. The unit was immediately removed from the patient and upon examination, the light panel was reported to have a crack just below the elbow bend and appeared to be charred. The damaged light panel was removed and a new panel was placed into the saphlite system. The case was completed with the new panel without any occurances.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221601-2002-00004 |
| MDR Report Key | 383801 |
| Report Source | 05,07 |
| Date Received | 2002-03-19 |
| Date of Report | 2002-03-19 |
| Date of Event | 2002-02-21 |
| Date Facility Aware | 2002-02-26 |
| Date Mfgr Received | 2002-02-21 |
| Date Added to Maude | 2002-03-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DENISE LIMA |
| Manufacturer Street | 600 AIRPORT ROAD |
| Manufacturer City | FALL RIVER MA 02720 |
| Manufacturer Country | US |
| Manufacturer Postal | 02720 |
| Manufacturer Phone | 5086776439 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SP CE SAPH3 SS LIGHT PANEL |
| Generic Name | SAPHLITE SYSTEM LIGHT PANEL |
| Product Code | FBM |
| Date Received | 2002-03-19 |
| Model Number | 89-2718 |
| Catalog Number | 89-2718 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 372867 |
| Manufacturer | GENZYME BIOSURGERY A DIVISION OF GENZYME |
| Manufacturer Address | 600 AIRPORT RD. FALL RIVER MA 02720 US |
| Baseline Brand Name | SP CE SAPH3 SS LIGHT PANEL |
| Baseline Generic Name | LIGHT PANEL |
| Baseline Model No | 89-2718 |
| Baseline Catalog No | 89-2718 |
| Baseline Device Family | VS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K960400 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-19 |