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

Model Number 9630-4

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One of the legs was bending.

• Brand Name: ALL-IN-ONE COMMODE (COATED) 9153629773
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): AQUATEC OPERATIONS GMBH; alemannenstrasse 10; isny 88316 ; GM 88316
• Manufacturer (Section G): AQUATEC OPERATIONS GMBH; alemannenstrasse 10; isny 88316 ; GM 88316
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5966761
• MDR Text Key: 55670445
• Report Number: 3007231105-2016-00110
• Device Sequence Number: 1
• Product Code: INN
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• 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: 08/31/2016
• 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 Weight: 104