MAUDE Adverse Event Report: INVACARE CORPORATION 96 SERIES BEDSIDE COMMODE; ADAPTOR, HYGIENE

Model Number 9630

Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 05/26/2016

Event Type  malfunction  

Event Description

Patient was assisted to bedside commode.She was attempting to get more comfortable and shifted her weight.She was not attempting to stand.The seat of the commode detached and seat and patient fell to floor.The clips did not hold.Patient's weight was (b)(6).Patient was bruised but not injured otherwise.

• Brand Name: 96 SERIES BEDSIDE COMMODE
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE CORPORATION; one invacare way; elyria OH 44035
• MDR Report Key: 5723277
• MDR Text Key: 47343426
• Report Number: 5723277
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9630
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2016
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 133