ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754 9650

MAUDE Adverse Event Report

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).

Event Text Entries

[139418213] The phlebotomist called out that patient was "folded" in the commode. Patient had gotten out of bed without assistance because she "didn't want to bother anyone". Bed alarm was not activated. Patient was using bedside commode and it collapsed underneath her. Patient was assessed by rn then pa and patient was free of injury. Bedside commode had a bar that popped out of it causing it the bucket to fall through. Commode taken out of service.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8439205
MDR Report Key8439205
Date Received2019-03-21
Date of Report2019-03-19
Date of Event2019-03-13
Report Date2019-03-19
Date Reported to FDA2019-03-19
Date Reported to Mfgr2019-03-21
Date Added to Maude2019-03-21
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754
Generic NameADAPTOR, HYGIENE
Product CodeILS
Date Received2019-03-21
Model Number9650
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINVACARE CORPORATION (TW)
Manufacturer Address39400 TAYLOR PKWY NORTH RIDGEVILLE OH 44035 US 44035


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.