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

Model Number IH1900IH3652GW

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

A return was issued and the product is awaiting receipt and/or evaluation. a follow up will be filed if/when any additional information is provided.

Event Description

Tub was leaking at the bottom of the door.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: plumbing unable to test.No test fixture.Complaint was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: plumbing unable to test.No test fixture.Tub was leaking at the bottom of the door.

• Brand Name: SITZ BATH 1616700692
• Type of Device: BATH, SITZ, NONPOWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5087211
• MDR Text Key: 26416538
• Report Number: 1525712-2015-04579
• Device Sequence Number: 1
• Product Code: ILM
• 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: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH1900IH3652GW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• 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