MAUDE Adverse Event Report: INNOVATION PRODUCTS UNLIMITED, INC. INNOVATION PRODUCTS UNLIMITED SHOWER CHAIR; CHAIR, ADJUSTABLE, MECHANICAL

Device Problem Break (1069)

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

Event Date 01/25/2019

Event Type  malfunction  

Event Description

Resident was being transferred to shower chair and the shower chair broke into pieces.

• Brand Name: INNOVATION PRODUCTS UNLIMITED SHOWER CHAIR
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): INNOVATION PRODUCTS UNLIMITED, INC.; niles MI 49120
• MDR Report Key: 8297165
• MDR Text Key: 135611802
• Report Number: MW5083633
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 81