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

Device Problem Break (1069)

Patient Problems Fall (1848); Injury (2348)

Event Date 08/30/2019

Event Type  malfunction  

Event Description

Resident was sitting on shower chair commode when the front snapped and she fell resulting in scratches to her thigh.Fda safety report id# (b)(4).

• Brand Name: SHOWER CHAIR COMMODE INNOVATIVE PRODUCTS UNLIMITED
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): INNOVATIVE PRODUCTS UNLIMITED, INC.
• MDR Report Key: 8974973
• MDR Text Key: 158638591
• Report Number: MW5089633
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• 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 Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 98