MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-30 for ATTACHABLE VOIDING STOOL manufactured by Liebel-flarsheim Co..
[19167748]
Cysto table being used with "voiding stool" attached. Pt in sitting position on voiding stool. While the physician doing the "filling and voiding cystometrogram" (for pt with stress incontinence and vaginal vault prolapse) the table was being positioned , loud noise was heard, and pt seen at an angle. The bed was tilted so pt's fall was broken. Pt did not fall. It appeared that screws on voiding stool got caught on side of cystol table, causing stool to break off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 28902 |
| MDR Report Key | 28902 |
| Date Received | 1995-08-30 |
| Date of Report | 1995-02-20 |
| Date of Event | 1995-02-03 |
| Date Facility Aware | 1995-02-13 |
| Report Date | 1995-02-20 |
| Date Reported to Mfgr | 1995-02-20 |
| Date Added to Maude | 1995-12-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTACHABLE VOIDING STOOL |
| Generic Name | ATTACHABLE VOIDING STOOL |
| Product Code | EYH |
| Date Received | 1995-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29878 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 E GALBRAITH RD CINCINNATI OH 452156305 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-08-30 |