MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-31 for CHAMPION DIALYSIS CHAIR (CHAMPION) 542T52-54 542T52 manufactured by Champion.
[15262238]
Employee was cleaning the dailysis champion chair with a 1% bleach wipe and suddenly her finger was pinched in the hinge assembly. Right index finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 209624 |
| MDR Report Key | 209624 |
| Date Received | 1998-12-31 |
| Date of Report | 1998-07-08 |
| Date of Event | 1998-07-04 |
| Date Facility Aware | 1998-07-04 |
| Report Date | 1998-07-08 |
| Date Reported to FDA | 1998-07-08 |
| Date Reported to Mfgr | 1998-07-08 |
| Date Added to Maude | 1999-02-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | CHAMPION DIALYSIS CHAIR (CHAMPION) |
| Generic Name | 54-RECLINER CHAIR |
| Product Code | FIA |
| Date Received | 1998-12-31 |
| Model Number | 542T52-54 |
| Catalog Number | 542T52 |
| Lot Number | 1434 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 203436 |
| Manufacturer | CHAMPION |
| Manufacturer Address | 2601 INDUSTRIAL PARKWAY ELKHART ID * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 1998-12-31 |