MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-29 for LUMEX * 6433A-2 manufactured by Gf Health Products, Inc.
[6009854]
Patient put her weight on the arms of one of our portable drop arm commodes and one of the drop arms gave way. She fell to the floor hit her mouth and damaged some of her teeth. After the incident it was noticed that the drop arm that gave way wobbled about 1/2 an inch compared to a new commode that did not wobble at all. It was also noticed of the commode involved in the incident that the drop arm locking mechanism would release when pressure was put on the vertical side of the drop arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4934884 |
| MDR Report Key | 4934884 |
| Date Received | 2015-06-29 |
| Date of Report | 2015-06-29 |
| Date of Event | 2015-06-23 |
| Report Date | 2015-06-29 |
| Date Reported to FDA | 2015-06-29 |
| Date Reported to Mfgr | 2015-07-23 |
| Date Added to Maude | 2015-07-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | LUMEX |
| Generic Name | COMMODE |
| Product Code | INB |
| Date Received | 2015-06-29 |
| Model Number | * |
| Catalog Number | 6433A-2 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GF HEALTH PRODUCTS, INC |
| Manufacturer Address | 2935 NORTHEAST PARKWAY ATLANTA GA 30360 US 30360 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-29 |