MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-03-07 for SUREPATH PRECOAT SLIDE 080-10010-03 manufactured by Tripath Imaging, Inc..
[15184560]
Customer called to complain that they have had a problem with slides having shards of glass in the packaging. Employees have been cutting their hands on the slides and recently an employee had a piece go in her eye when the slide was placed under the clip on the microscope stage. The cytotechnologist felt something sharp in her eye just as she placed the slide under the clip. The employee went to the doctor and had scratched the eye. According to the doctor, cytotechnologists do not blink their eyes as much, thus causing the eye to be open and dry. There was no damage to the eye and she was treated with eye drops.
Patient Sequence No: 1, Text Type: D, B5
[15590611]
The lab was not able to return the slide for evaluation or provide a lot number. The device in question is a standard glass microscope slide commonly used for cervical cytology. There is a risk of breakage with any glass item. A capa has been initiated to investigate the event determine if any action is possible to prevent recurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062336-2008-00003 |
| MDR Report Key | 1011970 |
| Report Source | 05,07 |
| Date Received | 2008-03-07 |
| Date of Report | 2008-03-07 |
| Date of Event | 2008-02-21 |
| Date Mfgr Received | 2008-02-21 |
| Date Added to Maude | 2009-12-30 |
| 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 | KENNITH EDDS, PH.D, SR. DIRECTOR |
| Manufacturer Street | 4025 STIRRUP CREEK DRIVE 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 PRECOAT SLIDE |
| Generic Name | SUREPATH LIQUID-BASED PAP TEST |
| Product Code | OHL |
| Date Received | 2008-03-07 |
| Model Number | NA |
| Catalog Number | 080-10010-03 |
| Lot Number | NOT KNOWN |
| 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, INC. |
| Manufacturer Address | BURLINGTON NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-07 |