MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-18 for LUMIVIEW 20510S SAME manufactured by Welch Allyn, Inc..
[257980]
User received a burn on the forehead between the eyebrows. Cause was attributed to the adjustment screw being heated by the lamp housing on the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316463-2002-00003 |
| MDR Report Key | 417747 |
| Report Source | 05 |
| Date Received | 2002-09-18 |
| Date of Report | 2002-09-18 |
| Date of Event | 2002-08-16 |
| Date Mfgr Received | 2002-08-23 |
| Date Added to Maude | 2002-09-24 |
| 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 | DAVID KLEMENTOWSKI |
| Manufacturer Street | 4341 STATE STREET ROAD |
| Manufacturer City | SKANEATELES FALLS NY 13153 |
| Manufacturer Country | US |
| Manufacturer Postal | 13153 |
| Manufacturer Phone | 3156854133 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMIVIEW |
| Generic Name | PORTABLE BINOCULAR MICROSCOPE |
| Product Code | ERA |
| Date Received | 2002-09-18 |
| Model Number | 20510S |
| Catalog Number | SAME |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 406780 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE STREET ROAD SKANEATELES FALLS NY 13153 US |
| Baseline Brand Name | LUMIVIEW |
| Baseline Generic Name | BINOCULAR MICROSCOPE |
| Baseline Model No | 20510S |
| Baseline Catalog No | 20510S |
| Baseline Device Family | LUMIVIEW |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955043 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-09-18 |