MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-07-14 for 7688 L A NA manufactured by Crow River Industries, Inc..
[15029058]
Report of alleged "pt injured while using a crow river lift. " user was trying to unfold the platform of the lift, when it allegedly deployed rapidly & struck her in the head. User received five stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183897-1998-00002 |
| MDR Report Key | 177494 |
| Report Source | 08 |
| Date Received | 1998-07-14 |
| Date of Report | 1998-07-14 |
| Date of Event | 1998-06-23 |
| Date Mfgr Received | 1998-06-23 |
| Device Manufacturer Date | 1993-11-01 |
| Date Added to Maude | 1998-07-17 |
| 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 | MA |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7688 L A |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1998-07-14 |
| Model Number | 7688 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 4.5 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 172589 |
| Manufacturer | CROW RIVER INDUSTRIES, INC. |
| Manufacturer Address | 850 STATE HWY. 55 P.O. BOX 70 BROOTEN MN 56316 US |
| Baseline Brand Name | MINI-VANGATER LIFT |
| Baseline Generic Name | WHEELCHAIR LIFT |
| Baseline Model No | 7688 |
| 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; 2. Other | 1998-07-14 |