MAUDE Adverse Event Report: INNOVATIVE PRODUCTS UNLIMITED DELUXE SHOWER CHAIR, COMMODE; CHAIR, ADJUSTABLE, MECHANICAL

Model Number SCC700

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

Elder was sitting on shower chair while cna applying cream to feet.The right shower chair back support bar broke.Elder fell backward & bumped her head by the wall as cna assisted her to the floor.Rn trauma assessment & neuros completed.No injury noted, neuro checks began per policy.Md and family informed.Fda safety report id #: (b)(4).

• Brand Name: DELUXE SHOWER CHAIR, COMMODE
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): INNOVATIVE PRODUCTS UNLIMITED; niles MI 49120
• MDR Report Key: 10275832
• MDR Text Key: 199223148
• Report Number: MW5095526
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCC700
• 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: 75 YR
• Patient Weight: 78