MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-11-04 for CAROUSEL * manufactured by Arjo Manufacturing Co..
[115463]
Pt slipped out of the carousel on to a wet floor. No injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-1998-00003 |
| MDR Report Key | 195124 |
| Report Source | 05,06 |
| Date Received | 1998-11-04 |
| Date of Report | 1998-11-03 |
| Date of Event | 1998-09-14 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 1998-11-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAROUSEL |
| Generic Name | PATIENT BATH TUBE |
| Product Code | JTQ |
| Date Received | 1998-11-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 189575 |
| Manufacturer | ARJO MANUFACTURING CO. |
| Manufacturer Address | 102 GRANT STREET AURORA NE 68818 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-11-04 |