MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-07-14 for PROBE 8065010920 manufactured by Alcon Precision Device-sinking Spring.
[17765221]
Reporter noted illuminator probe tip melted. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[17967961]
This product/lot number was not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2006-00006 |
| MDR Report Key | 738376 |
| Report Source | 05,07 |
| Date Received | 2006-07-14 |
| Date of Report | 2006-06-14 |
| Date of Event | 2006-06-14 |
| Date Mfgr Received | 2006-06-14 |
| Date Added to Maude | 2006-07-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON PRECISION DEVICE-SINKING SPRING |
| Manufacturer Street | 714 COLUMBIA AVENUE |
| Manufacturer City | SINKING SPRING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE |
| Generic Name | PROBE |
| Product Code | HJD |
| Date Received | 2006-07-14 |
| Model Number | 8065010920 |
| Catalog Number | 8065010920 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 726266 |
| Manufacturer | ALCON PRECISION DEVICE-SINKING SPRING |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-14 |