MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-10-21 for 7684 NA manufactured by Nellcor Puritan Bennett.
[103263]
Report of alleged "user fractured her leg while getting off the platform. She would lower lift to ground, then start to operate her chair to get off. She would get approx 3/4 of the way off, and the back part of her chair caught the barriers. She fell out of the chair and broke her leg. She was not wearing her seat belt at the time of incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183897-1997-00007 |
| MDR Report Key | 128991 |
| Report Source | 04 |
| Date Received | 1997-10-21 |
| Date of Report | 1997-09-29 |
| Date Mfgr Received | 1997-09-29 |
| Device Manufacturer Date | 1996-11-01 |
| Date Added to Maude | 1997-11-03 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7684 |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1997-10-21 |
| Model Number | 7684 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 126176 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 14800 28TH AVE. N. PLYMOUTH MN 55447 US |
| Baseline Brand Name | VANGATER LIFT |
| Baseline Generic Name | WHEELCHAIR LIFT |
| Baseline Model No | 7684 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | AUTOMATIC VAN LIFT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900417 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-21 |