MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-08-29 for CYTOLYT SOLUTION ASSEMBLY (NON-GYN) 0236041 0236080/0236050 manufactured by Cytyc Corp..
[719238]
Cytyc technical service received a call from rep. She stated that facility was called by a doctor's office who reported, that a pt had ingested a cytolyt solution vial. Technical service instructed re[ as to where to locate the msds to fax to the doctor's office and also suggested that the pt be sent to the emergency room for follow-up. Facility repeatedly attempted to contact the doctor's office, but has not been able to follow up on the pt. It is unk at this time whether the pt received medical treatment or the status of the pt. If cytyc becomes aware of any add'l info, it will be submitted via a supplemental report.
Patient Sequence No: 1, Text Type: D, B5
[7864878]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2007-00019 |
| MDR Report Key | 906461 |
| Report Source | 00 |
| Date Received | 2007-08-29 |
| Date of Report | 2007-08-29 |
| Date of Event | 2007-07-31 |
| Date Mfgr Received | 2007-07-31 |
| Date Added to Maude | 2008-02-28 |
| 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 | LISA LACROIX, SPECIALIST |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638854 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYTOLYT SOLUTION ASSEMBLY (NON-GYN) |
| Generic Name | REAGENT/BUFFER FOR CYTOLOGY SLIDE PREP. |
| Product Code | LEA |
| Date Received | 2007-08-29 |
| Model Number | 0236041 |
| Catalog Number | 0236080/0236050 |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 951626 |
| Manufacturer | CYTYC CORP. |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-29 |