MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-02-21 for 7688 LA MINI-VANGATER LIFT NA manufactured by Aequitron Medical, Inc..
[47949]
Report of alleged "while operating the remote fold and unfold buttons back and forth, to deploy lift with no effect, user grabbed right side of platform and pulled. Platform fell out of lift injuring user on her left side. User did not receive medical attention after incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183897-1997-00002 |
| MDR Report Key | 71452 |
| Report Source | 07 |
| Date Received | 1997-02-21 |
| Date of Report | 1997-01-22 |
| Date of Event | 1997-01-22 |
| Date Mfgr Received | 1997-01-22 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 1997-02-28 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7688 LA MINI-VANGATER LIFT |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1997-02-21 |
| Model Number | 7688 LA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| 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 | 71346 |
| Manufacturer | AEQUITRON MEDICAL, INC. |
| Manufacturer Address | 14800 28TH AVE. NORTH PLYMOUTH MN 55447 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-21 |