MAUDE Adverse Event Report: AQUATEC OPERATIONS GMBH TOILET SAFETY FRAME 9153641786; ADAPTOR, HYGIENE

Model Number 1535001

Device Problems Material Separation (1562); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Seats separating from crossbar (secure part that attaches to the toilet) and are no longer sitting flat on the toilet bowl.

• Brand Name: TOILET SAFETY FRAME 9153641786
• 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: 5184169
• MDR Text Key: 30220559
• Report Number: 3007231105-2015-00145
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1535001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• 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