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

Model Number 9630-1

Device Problems Bent (1059); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up will be sent if the product or additional information is obtained.

Event Description

The dealer stated the unit has bent legs out of the box.The item was not delivered to a patient, therefore, no injury or property damage was reported.

• 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 44035 ; 8003336900
• MDR Report Key: 4962982
• MDR Text Key: 23418296
• Report Number: 3007231105-2015-00119
• 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
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• 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: 07/09/2015
• 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