MAUDE Adverse Event Report: UNKNOWN ALL-IN-ONE COMMODE 9153629772; ADAPTOR, HYGIENE

Model Number 9630-1

Device Problem Crack (1135)

Patient Problem Physical Entrapment (2327)

Event Type  malfunction  

Event Description

Dealer stated that the seat for a 9630-1 commode is cracked in the right front corner causing user to sustain a pinching injury.

• Brand Name: ALL-IN-ONE COMMODE 9153629772
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4339334
• MDR Text Key: 5217954
• Report Number: 3007231105-2014-00111
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9630-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2014
• 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
• Patient Weight: 68