MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-25 for XYLENE AR 8668-20 manufactured by Mallinckrodt Specialty Chemical Company.
[10390]
Customer has used the xylene product for over 40 years and always experienced a reaction to it, such as asthma and other respiratory ailments. Upon using this particular lot her symptoms became more serious with periods of blackout, nausea, irregular heartbeat. Cardiologist diaagnosed aterial fibrillation and prescribed heart medicaation. Customer doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1994-00010 |
| MDR Report Key | 14145 |
| Date Received | 1994-04-25 |
| Date of Report | 1994-04-18 |
| Date Facility Aware | 1993-05-04 |
| Report Date | 1994-04-18 |
| Date Reported to FDA | 1994-04-18 |
| Date Reported to Mfgr | 1994-05-14 |
| Date Added to Maude | 1994-06-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XYLENE AR |
| Generic Name | HISTOLOOGY SOLVENT |
| Product Code | ICF |
| Date Received | 1994-04-25 |
| Model Number | NA |
| Catalog Number | 8668-20 |
| Lot Number | 8668 KJNL |
| ID Number | 5 GALLON SIZE |
| Operator | OTHER |
| Device Availability | * |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14141 |
| Manufacturer | MALLINCKRODT SPECIALTY CHEMICAL COMPANY |
| Manufacturer Address | P.O. BOX 800 PARIS BYPASS PARIS KY 40361 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-25 |