MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-11 for SUREPATH COLLECTION VIAL GYN-0500-V manufactured by Tripath Imaging.
[20161558]
In 2008, tripath imaging technical support received a report from a private ob/gyn clinic in other country, that a pt may have ingested surepath preservative fluid. The pt put the fluid into his mouth, but spat out most if not all of it because of the taste. The material safety data sheet (msds) was provided to the caller. The fluid primarily contains deionized water and ethanol, but also a small amount of methanol (1. 2%). The vial is used to preserve a cervical cytology sample for analysis. It is not clear how the pt obtained access to the vial or if he actually swallowed the contents. The physician involved in the incident reported that she contacted the pt's mother after the event and no adverse effects were reported. No malfunction, user error.
Patient Sequence No: 1, Text Type: D, B5
[20554068]
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. It further relevant info becomes available, an amended report will be generated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062336-2008-00007 |
| MDR Report Key | 1172640 |
| Report Source | 05 |
| Date Received | 2008-09-11 |
| Date of Report | 2008-09-11 |
| Date of Event | 2008-08-12 |
| Date Mfgr Received | 2008-08-12 |
| Date Added to Maude | 2009-08-12 |
| 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. DIRECTOR, |
| 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 | 2008-09-11 |
| Model Number | COLLECTION VIAL |
| Catalog Number | GYN-0500-V |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIPATH IMAGING |
| Manufacturer Address | 780 PLANTATION DRIVE BURLINGTON NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-11 |