MAUDE Adverse Event Report: INVACARE CLEVELAND STREET SITZ BATH 1616700692; BATH, SITZ, NONPOWERED

Model Number IH3750

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The door seal on the tub was no longer adhering to the door and there was a space between the door and the seal.

• Brand Name: SITZ BATH 1616700692
• Type of Device: BATH, SITZ, NONPOWERED
• Manufacturer (Section D): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer (Section G): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5450316
• MDR Text Key: 39136358
• Report Number: 1219590-2016-00016
• Device Sequence Number: 1
• Product Code: ILJ
• 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: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH3750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• 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