MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2002-04-12 for PRESERV CYT SOLUTION VIAL ASSEMBLY (GYN) * manufactured by Cytyc Corporation.
[262170]
In 2002, a secretary for dr reported an incident to cytyc's technical suport (ts) department that was reported to her by an office mgr at a facility. Reporter claimed that office mgr had called and reported an incident where preservcyt solution containing a pt's cervical sample had been accidentally splashed into an employee's eyes at their facility. The employee involved whose name is unknown at this time is a medical assistant working in the cytology department for the medical office. Ts contacted the office mgr explained that the employee had rinsed their eyes for 15 to 25 minutes as suggested in the material safety data sheet (msds) for preservcyt solution. Office mgr had the employee go to the er due to minor eye irritation. After further rinsing of the eye the er doctor determine that no further medcial attention would be required. Office mgr also informed ts that the medical assistant has not experienced any lingering adverse effect as a result of this incident. There have been no further reports regarding the incident received by cytyc in the 24 since ts last spoke with the office mgr. If cytyc obtains add'l info it will be forwarded to the fda via a supplemental report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2002-00001 |
| MDR Report Key | 388786 |
| Report Source | 05,06,07 |
| Date Received | 2002-04-12 |
| Date of Report | 2002-04-11 |
| Date of Event | 2002-03-15 |
| Date Added to Maude | 2002-04-19 |
| 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 | DAN BRACCO |
| Manufacturer Street | 85 SWANSON ROAD |
| Manufacturer City | BOXBOROUGH MA 01719 |
| Manufacturer Country | US |
| Manufacturer Postal | 01719 |
| Manufacturer Phone | 9782663103 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESERV CYT SOLUTION VIAL ASSEMBLY (GYN) |
| Generic Name | REAGENT FOR CYTOLOGY SLIDE PREPERATION |
| Product Code | LEA |
| Date Received | 2002-04-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 377834 |
| Manufacturer | CYTYC CORPORATION |
| Manufacturer Address | 85 SWANSON RD. BOXBOROUGH MA 01719 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2002-04-12 |