MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-06-14 for PRESERVCYT SOLUTION ASSEMBLY (GYN) 70097-001 70098-001 manufactured by Cytyc Corporation.
[21259613]
Cytyc technical service received a call, inquiring about the methanol content in preservcyt solution. The caller informed technical service that a child had swallowed the contents of a preservcyt solution vial. Technical service then contacted the initial reporter, a nurse practitioner, she indicated that the child, reached for the loosely capped vial on top of the counter and ingested the preservcyt solution. It is unknown whether the vial contained a patient specimen or how much was actually ingested. Following ingestion, the child vomited and was taken to the emergency room. Technical service followed up with the nurse two days after the event and she reported that the child was ok and did not experience any further symptoms associated with the ingestion of preservcyt solution.
Patient Sequence No: 1, Text Type: D, B5
[21343218]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2007-00004 |
| MDR Report Key | 866089 |
| Report Source | 06 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-06-14 |
| Date of Event | 2007-05-15 |
| Date Mfgr Received | 2007-05-17 |
| Date Added to Maude | 2007-09-13 |
| 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 |
| 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 | PRESERVCYT SOLUTION ASSEMBLY (GYN) |
| Generic Name | REAGENT FOR CYTOLOGY SLIDE PREPARATION |
| Product Code | LEA |
| Date Received | 2007-06-14 |
| Model Number | 70097-001 |
| Catalog Number | 70098-001 |
| 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 | 848943 |
| Manufacturer | CYTYC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-14 |