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 |