MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-03-25 for SUREPATH PRESERVATIVE FLUID GYN-0500-V manufactured by Tripath Imaging, Inc..
[16496837]
This event was an accidental splash unrelated to the design or function of the device. In addition, the device product insert contains the following warning, "avoid splashing or generating aerosols. Operators should use appropriate hand, eye and clothing protection. " in this event, the operator was not wearing any eye protection.
Patient Sequence No: 1, Text Type: N, H10
[16702560]
A laboratory technician was discarding used syringing pipettes and was struck in the eye with a droplet of preservative fluid. The technician was not wearing protective eyewear. There were 24 samples in the batch being processed, one of which was from an hiv positive patient. The technician was treated with hiv prophylaxis medications as a precaution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062336-2008-00002 |
| MDR Report Key | 1023762 |
| Report Source | 06 |
| Date Received | 2008-03-25 |
| Date of Report | 2008-03-25 |
| Date of Event | 2008-02-28 |
| Date Mfgr Received | 2008-02-29 |
| Date Added to Maude | 2008-07-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 DR. SUITE 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 PRESERVATIVE FLUID |
| Generic Name | LIQUID BASED PAP SMEAR COLLECTION |
| Product Code | LEA |
| Date Received | 2008-03-25 |
| Catalog Number | GYN-0500-V |
| Lot Number | NOT KNOWN |
| 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 | 1021046 |
| Manufacturer | TRIPATH IMAGING, INC. |
| Manufacturer Address | BURLINGTON NC 27215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-03-25 |