MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-07-22 for STANDARD OPHTHALMOSCOPE 11710 manufactured by Welch Allyn, Inc..
[19495154]
An ophthalmoscope head melted on a wall transformer. The hand was not completely in the cradle on the transformer, causing lamp to be lit for 40 minutes. There was no patient involved and no injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[19644694]
H3: awaiting device return for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2005-00007 |
| MDR Report Key | 729240 |
| Report Source | 06 |
| Date Received | 2005-07-22 |
| Date of Report | 2005-07-15 |
| Date of Event | 2005-07-06 |
| Date Added to Maude | 2006-06-28 |
| 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 | CHRISTOPHER KLACZYK |
| Manufacturer Street | 4341 STATE ST ROAD |
| Manufacturer City | SKANEATELES FALLS NY 13153 |
| Manufacturer Country | US |
| Manufacturer Postal | 13153 |
| Manufacturer Phone | 3156854100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD OPHTHALMOSCOPE |
| Generic Name | OPHTHALMOSCOPE |
| Product Code | HLI |
| Date Received | 2005-07-22 |
| Model Number | 11710 |
| Catalog Number | 11710 |
| Lot Number | * |
| 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 | 717523 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | * SKANEATELES FALLS NY * US |
| Baseline Brand Name | STANDARD OPHTHALMOSCOPE |
| Baseline Generic Name | OPHTHALMOSCOPE |
| Baseline Model No | 11710 |
| Baseline Catalog No | 11710 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 76710 | 2005-07-22 |