MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-22 for PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES 02J27-11 manufactured by Abbott Molecular, Inc..
[20782667]
The probechek urovysion bladder cancer kit control slides are non-hybridized slides prepared with cultured normal male lymphoblast cells and cultured bladder cancer cell lines. Each control slide consists of two separate target areas in which each of the different cell types have been applied. The cell lines are harvested, fixed in suspension medium, and applied to the glass microscope slides in a method optimal for fish (fluorescence in situ hybridization). A customer reported receiving a broken probechek urovysion control slide. There was no report of injury. The probechek urovysion control slides package insert indicates that these slides contain human sourced and/or potentially infectious components. If the issue of customer receiving broken probechek slides were to recur, it is possible that customers could cut themselves with a potentially infectious slide. Therefore, recurrence of this issue could potentially cause or contribute to serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2013-00016 |
| MDR Report Key | 3588339 |
| Report Source | 07 |
| Date Received | 2014-01-22 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-22 |
| Date Mfgr Received | 2013-11-22 |
| Date Added to Maude | 2014-04-01 |
| 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 | JEENE LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES |
| Generic Name | MICROSCOPIC CONTROL SLIDES UED IN FISH TESTING |
| Product Code | NSD |
| Date Received | 2014-01-22 |
| Catalog Number | 02J27-11 |
| Lot Number | 448596 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-22 |