MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-10-22 for 9684 NA manufactured by Crow River Industries, Inc..
[117768]
Report of alleged "pt injured while using a crow river lift. " pt allegedly fell off his lift, and sustained injuries to the face and shoulder. Pt alleges that the platform tilted down which caused the wheelchair and himself to roll off and fall to the ground. Pt did have x-rays after the accident, but did not receive any broken bones. He has not been back to the dr since the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183897-1998-00004 |
| MDR Report Key | 193516 |
| Report Source | 08 |
| Date Received | 1998-10-22 |
| Date of Report | 1998-10-21 |
| Date Mfgr Received | 1998-08-03 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 1998-10-28 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9684 |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1998-10-22 |
| Returned To Mfg | 1998-10-13 |
| Model Number | 9684 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 188024 |
| Manufacturer | CROW RIVER INDUSTRIES, INC. |
| Manufacturer Address | 850 STATE HWY. 55 PO BOX 70 BROOTEN MN 56316 US |
| Baseline Brand Name | VANGATER II LIFT |
| Baseline Generic Name | WHEELCHAIR LIFT |
| Baseline Model No | 9684 |
| 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 | K952946 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-22 |