MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-02-19 for CHIEF SR 107SR NA manufactured by Redman, Inc..
[15745723]
Use was in the standing position, when the chair tipped forward allegedly bruising his knees. He stated that he was not wearing the seat belt or chest harness when the accident occurred. He was wearing his knee bolster.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025750-1997-00001 |
| MDR Report Key | 71150 |
| Report Source | 04 |
| Date Received | 1997-02-19 |
| Date of Report | 1997-02-19 |
| Date of Event | 1997-01-18 |
| Date Mfgr Received | 1997-01-20 |
| Device Manufacturer Date | 1996-09-01 |
| Date Added to Maude | 1997-02-26 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHIEF SR |
| Generic Name | DIRECT DRIVE POWER CHAIR |
| Product Code | IPL |
| Date Received | 1997-02-19 |
| Model Number | 107SR |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 71046 |
| Manufacturer | REDMAN, INC. |
| Manufacturer Address | 945 E OHIO STE 4 TUCSON AZ 85714 US |
| Baseline Brand Name | CHIEF SR |
| Baseline Generic Name | STAND RECLINE POWER CHAIR |
| Baseline Model No | 107SR |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K940919 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-02-19 |