MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-04-23 for CYTOLYT SOLUTION 0236004 NA manufactured by Hologic, Inc..
[835402]
Note that though the event occurred on (b) (6) 2008, (b) (4) was made aware of this event on (b) (4) 2008. A patient from (b) (6) ingested a sample of cytolyt solution. The male patient was already at the hospital for another injury when this happened. A cytolyt pre-filled cup was left on the bedside and the patient drunk 2/3 of the liquid (20 cc). The lab staff administered ethilic alchohol as an antidote of methanol that is part of the cytolyt solution. The pt received first aid measures from the laboratory and was hospitalized the same day. The patient went out of the hospital and was doing well.
Patient Sequence No: 1, Text Type: D, B5
[7993797]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2008-00053 |
| MDR Report Key | 1033072 |
| Report Source | 07 |
| Date Received | 2008-04-23 |
| Date of Report | 2008-04-21 |
| Date of Event | 2008-01-04 |
| Date Mfgr Received | 2008-04-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RAJ KASBEKAR, MANAGER |
| 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 | CYTOLYT SOLUTION |
| Generic Name | REAGENT/BUFFER FOR CYTOLOGY SLIDE PREP |
| Product Code | LEA |
| Date Received | 2008-04-23 |
| 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 | 2008-04-23 |