MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-02-19 for PRESERVCYT SOLUTION manufactured by Hologic Inc (cytyc Corporation).
[20512160]
A child drank 3/4 of the 20 ml preservcyt vial solution (contains methanol). Customer contacted poison control and sent child to emergency room. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[20833893]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2009-00025 |
| MDR Report Key | 1371572 |
| Report Source | 06 |
| Date Received | 2009-02-19 |
| Date of Report | 2009-02-18 |
| Date of Event | 2009-02-17 |
| Date Mfgr Received | 2009-02-17 |
| Date Added to Maude | 2009-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RAJ KASBEKAR |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638858 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESERVCYT SOLUTION |
| Generic Name | REAGENT FOR CYTOLOGY SLIDE PREPARATION |
| Product Code | LEA |
| Date Received | 2009-02-19 |
| Lot Number | NI |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC (CYTYC CORPORATION) |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-02-19 |