MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-14 for SUREPATH COLLECTION VIAL manufactured by Tripath Imaging, Inc..
[20344739]
In 2007, tripath imaging rec'd a report from a ob/gyn clinic, that while a pt was in the office, she mistakenly drank a 10ml vial containing surepath preservative fluid. That fluid contains mostly ethanol but also 120 microliters of methanol (1. 2%). The vial is used to preserve a cervical cytology sample for analysis. The pt clearly misunderstood the nurse's instructions. Pt was sent to an er for eval and poison control was called. Pt was given fluids and released the same day. She is apparently fine with no side effects. No malfunction, user error.
Patient Sequence No: 1, Text Type: D, B5
[20611196]
This was clearly an unusual accident and user error; there was no device malfunction. Decision to file was based on the fact that the pt sought medical help as a result of using the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062336-2007-00002 |
| MDR Report Key | 865890 |
| Report Source | 05 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-06-14 |
| Date of Event | 2007-05-15 |
| Date Mfgr Received | 2007-05-15 |
| 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 | KENNETH EDDS, SR DIR |
| Manufacturer Street | 4025 STIRRUP CREEK DRIVE STE 400 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9192067140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUREPATH COLLECTION VIAL |
| Generic Name | CERVICAL CYTOLOGY COLLECTION VIAL |
| Product Code | LEA |
| Date Received | 2007-06-14 |
| Model Number | COLLECTION VIAL |
| Catalog Number | SUREPATH |
| Lot Number | UNK |
| 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 | 850197 |
| Manufacturer | TRIPATH IMAGING, INC. |
| Manufacturer Address | 780 PLANTATION DR. BURLINGTON NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-14 |