MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-06-03 for STRATUSOCT 3000 NA manufactured by Carl Zeiss Meditec Inc.
[418098]
A patient experienced an electrostatic discharge when touching the device pt module. The discharge occurred in the vicinity of the pt's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918630-2005-00004 |
| MDR Report Key | 615698 |
| Report Source | 05 |
| Date Received | 2005-06-03 |
| Date of Report | 2005-05-26 |
| Date of Event | 2005-04-05 |
| Date Mfgr Received | 2005-05-15 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2005-06-22 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574353 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATUSOCT |
| Generic Name | OPTICAL CORNEAL TOMOGRAPHY |
| Product Code | HLI |
| Date Received | 2005-06-03 |
| Model Number | 3000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 605454 |
| Manufacturer | CARL ZEISS MEDITEC INC |
| Manufacturer Address | * * US |
| Baseline Brand Name | STRATUS OCT |
| Baseline Generic Name | OPTICAL CORNEAL TOMOGRAPHY |
| Baseline Model No | 3000 |
| Baseline Catalog No | 00203-01 |
| Baseline Device Family | OCT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K030433 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-06-03 |