MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-04-22 for HUTIV TABLE ASSY STD W/COLOR HUT TABLE 400006 manufactured by Liebel-flarsheim Co..
[844363]
Customer reported that a female was undergoing a urology procedure for incontinence. She reported that they attached the voiding stool to the urology table. With the patient sitting on the stool they started to raise the patient into position when the voiding stool and patient tilted sideway. The customer removed the patient from the stool. She reported that there were no injuries to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8060977]
Liebel flarsheim field service engineer report. Fse replace tower side table support rail and tower side thumb screw latch on voiding stool due to damaged threads on both items. Unit functional and returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2008-00160 |
| MDR Report Key | 1032305 |
| Report Source | 05,06,07 |
| Date Received | 2008-04-22 |
| Date of Report | 2008-03-28 |
| Date of Event | 2008-03-28 |
| Date Mfgr Received | 2008-03-28 |
| Device Manufacturer Date | 1960-04-01 |
| Date Added to Maude | 2008-08-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUTIV TABLE ASSY STD W/COLOR |
| Generic Name | UROLOGY TABLE |
| Product Code | MMZ |
| Date Received | 2008-04-22 |
| Model Number | HUT TABLE |
| Catalog Number | 400006 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1030848 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-22 |