MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-02-27 for CYTOLYT SOLUTION CENTRIFUGE TUBE (30ML) 0200012 0236080 manufactured by Cytyc Corp..
[18478933]
In 2001 reporter called cytyc's technical service dept to report that one of his staff members accidentally splashed cytolyt solution into their eyes. The incident occurred when the employee was snapping the lid of the container closed and a small amount of cytolyt solution containing a sputum sample splashed into their eyes. Reporter had the employee flush their eyes with water for 15 minutes according to the instructions in the material safety data sheet (msds). He also stated that after flushing their eyes with water the employee did not experience any pain or other symptoms, but that the employee was referred to their employee health dept as a precaution. During a follow-up phone call to the customer in 2/01 reporter reiterated that the employee did not splash very much solution into their eyes and that their eyes were immediately flushed with water after the incident. The employee went to an optometrist who determined that no further medical attention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2001-00002 |
| MDR Report Key | 318172 |
| Report Source | 05,06 |
| Date Received | 2001-02-27 |
| Date of Report | 2001-02-27 |
| Date of Event | 2001-02-05 |
| Date Added to Maude | 2001-03-05 |
| 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 RD |
| 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 | CYTOLYT SOLUTION CENTRIFUGE TUBE (30ML) |
| Generic Name | TRANSPORT MEDIUM FOR CYTOLOGIC SAMPLES |
| Product Code | IFB |
| Date Received | 2001-02-27 |
| Model Number | 0200012 |
| Catalog Number | 0236080 |
| Lot Number | NI |
| ID Number | NA |
| 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 | 307696 |
| Manufacturer | CYTYC CORP. |
| Manufacturer Address | 85 SWANSON RD. BOXBOROUGH MA 01719 US |
| Baseline Brand Name | CYTOLYT SOLUTION CENTRIFUGE TUBE (30ML) |
| Baseline Generic Name | CYTOLYT TUBE |
| Baseline Model No | 0200012 |
| Baseline Catalog No | 0236080 |
| Baseline ID | NA |
| Baseline Device Family | SOLUTIONS (NON-GYN) |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2001-02-27 |