MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-07-27 for CYTOLYT 0236004 NA manufactured by Hologic, Inc.
[1168654]
Pt ingested a sample of cytolyt solution, 30ml. The pt displayed symptoms of methanol intoxication. Ethanol and hemodialysis treatment was performed. Methanol blood levels were monitored. Pt was discharged when concentrations dropped below toxicity level. The pt was in good health when discharged from the hosp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2009-00101 |
| MDR Report Key | 1422398 |
| Report Source | 06 |
| Date Received | 2009-07-27 |
| Date of Report | 2009-07-01 |
| Date of Event | 2009-07-01 |
| Date Mfgr Received | 2009-07-01 |
| Date Added to Maude | 2010-02-02 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER SULLIVAN, SPECIALIST |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638912 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYTOLYT |
| Generic Name | REAGENT/BUFFER FOR CYTOLOGY SLIDE PREP |
| Product Code | LEA |
| Date Received | 2009-07-27 |
| Model Number | 0236004 |
| Catalog Number | NA |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-27 |