MAUDE Adverse Event Report: UNKNOWN ALL-IN-ONE COMMODE (COATED) 9153629773; ADAPTOR, HYGIENE

Model Number 9630-4

Device Problem Crack (1135)

Patient Problem Physical Entrapment (2327)

Event Type  malfunction  

Event Description

End user reported that the seat on his 9630-4 commode cracked along the supports underneath, user sustained a pinch.

Manufacturer Narrative

This product was made by invacare at either invamex or aquatec (b)(4) and invacare has chosen to file this report utilizing the invamex cfn/fei registration.

• Brand Name: ALL-IN-ONE COMMODE (COATED) 9153629773
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4705644
• MDR Text Key: 5719240
• Report Number: 9616091-2015-01098
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9630-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other