MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-05-21 for 7684 NA manufactured by Nellcor Puritan Bennett, Inc..
[61454]
Report of pt being transported from one location to another by a commercial transport service. She was moved on to lift, the lift plate stop folded over her left foot causing personal injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183897-1997-00005 |
| MDR Report Key | 93581 |
| Report Source | 07 |
| Date Received | 1997-05-21 |
| Date of Report | 1997-04-23 |
| Date of Event | 1996-02-23 |
| Date Mfgr Received | 1997-04-23 |
| Date Added to Maude | 1997-05-30 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| 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 | 1997-05-21 |
| Model Number | 7684 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 92397 |
| Manufacturer | NELLCOR PURITAN BENNETT, INC. |
| Manufacturer Address | 14800 28TH AVE NORTH 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. Hospitalization | 1997-05-21 |