MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-12 for UROLOGY TABLE 40017 * manufactured by Allyn Medical Systems.
[63932]
When urology table was being positioned for x-ray, the table movement struck the verticle shaft of the lt stirrup. The locking mechanism was apparently not engaged to hold stirrup to table. The table movement pushed stirrup from table causing lt leg to fall. Pt had received spinal block and legs were secured to stirrups. Pt has scheduled appointment with neurologist due to numbness in rt hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011465 |
| MDR Report Key | 97575 |
| Date Received | 1997-06-12 |
| Date of Report | 1997-06-05 |
| Date of Event | 1997-05-29 |
| Date Added to Maude | 1997-06-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROLOGY TABLE |
| Generic Name | UROLOGY TABLE |
| Product Code | MMZ |
| Date Received | 1997-06-12 |
| Model Number | 40017 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 96281 |
| Manufacturer | ALLYN MEDICAL SYSTEMS |
| Manufacturer Address | 5198 RICHMOND RD CLEVELAND OH 44146 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-12 |