MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754 9650 manufactured by Invacare Corporation (tw).
[139418559]
While pt was sitting on bedside commode, metal bar on bottom frame of bedside commode broke off, causing pt to fall through. No injury to patient. Pt weight and use appropriate for equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8439214 |
| MDR Report Key | 8439214 |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-03 |
| Report Date | 2019-03-19 |
| Date Reported to FDA | 2019-03-19 |
| Date Reported to Mfgr | 2019-03-21 |
| Date Added to Maude | 2019-03-21 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754 |
| Generic Name | ADAPTOR, HYGIENE |
| Product Code | ILS |
| Date Received | 2019-03-21 |
| Model Number | 9650 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORPORATION (TW) |
| Manufacturer Address | 39400 TAYLOR PKWY NORTH RIDGEVILLE OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |