MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-08 for CITRASOLV manufactured by Decon Labs.
[100770581]
Citrasolv (decon laboratories) reagent was contaminated with gray-green to brown mucoid like substance which interfered with the clearing of tissue processed at the (b)(4). This resulted in tissue damage that requires re-processing (which is in process) at the minimum. Dates of use: (b)(6) 2016. Diagnosis or reason for use: used to clear tissue before paraffinization of tissue. Tissue is then cut and placed on slides for diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064007 |
| MDR Report Key | 5868015 |
| Date Received | 2016-08-08 |
| Date of Report | 2016-07-20 |
| Date of Event | 2016-07-15 |
| Date Added to Maude | 2016-08-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CITRASOLV |
| Generic Name | CITRASOLV |
| Product Code | KEM |
| Date Received | 2016-08-08 |
| Lot Number | 442167 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DECON LABS |
| Manufacturer Address | 460 GLENNIE CIRCLE KING OF PRUSSIA PA 19406 US 19406 |
| Brand Name | CITRASOLV |
| Generic Name | CITRASOLV |
| Product Code | KEM |
| Date Received | 2016-08-08 |
| Lot Number | 449165 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DECON LABS |
| Manufacturer Address | 460 GLENNIE CIRCLE KING OF PRUSSIA PA 19406 US 19406 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-08 |