MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-28 for HYDRADJUST UROLOGY TABLE HYDRADJUST DR 404002 manufactured by Liebel-flarsheim.
[18602714]
Urology table foot switch malfunctioned causing uncommanded movement of the table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2002-00022 |
| MDR Report Key | 402809 |
| Date Received | 2002-06-28 |
| Date of Report | 2002-06-24 |
| Date of Event | 2002-06-21 |
| Date Mfgr Received | 2002-06-24 |
| Date Added to Maude | 2002-07-05 |
| 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 | 0 |
| Manufacturer Contact | DAVE BENSON |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRADJUST UROLOGY TABLE |
| Generic Name | UROLOGY TABLE |
| Product Code | BWN |
| Date Received | 2002-06-28 |
| Model Number | HYDRADJUST DR |
| Catalog Number | 404002 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 391819 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US |
| Baseline Brand Name | HYDRADJUST UROLOGICAL TABLE |
| Baseline Generic Name | GENERAL SURGICAL |
| Baseline Model No | HYDRADJUST DR |
| Baseline Catalog No | 400033 |
| Baseline ID | * |
| Baseline Device Family | HYDRADJUST UROLOGICAL TABLE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K943581 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-28 |