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

Model Number 9630-4

Device Problems Crack (1135); Component Missing (2306); Naturally Worn (2988); Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Dealer stated that when the box was opened the rubber legs (rubber tips for the leg extensions) for a 9630-4 commode were missing from the box.Page1 of the operating instructions states a warning, "inspect rubber tips on the leg extensions for rips, tears, cracks or wear or if they are missing.Replace them immediately if any of these conditions exist".

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: 4706670
• MDR Text Key: 5665551
• Report Number: 1031452-2015-13413
• 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: 04/08/2015

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?: No
• 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: 04/08/2015
• 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