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

Model Number IH3652G

Device Problem Leak/Splash (1354)

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

On the door hinge is leaking water when the tub is filling with water.

Manufacturer Narrative

Additional/updated information was added to reflect the door hinge being returned to the manufacturer for evaluation.The result of the evaluation was that there was no defect to the hinge, so the original complaint issue could not be verified.It is unknown if there was an issue with the tub itself, as only the one part was returned for evaluation.*.

Event Description

On the door hinge is leaking water when the tub is filling with water.

• 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: 5195218
• MDR Text Key: 30467826
• Report Number: 1219590-2015-00161
• 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,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH3652G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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