MAUDE Adverse Event Report: COM-DA HEALTHCARE CO. LTD / REGULATORY INSIGHT INC. CAREX WEIGHT CAPACITY 300 LB SHOWER STOOL; ADAPTOR, HYGIENE

Device Problem Collapse (1099)

Patient Problem Fall (1848)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Sitting on home health supplied shower chair in shower, soaping washcloth when chair leg collapsed, fell to floor and unable to get up.Am 12 weeks out from posterior approach right hip replacement.Wife drug me to bedroom and had to call ambulance to get off the floor.Bruised left hip.Fda safety report id# (b)(4).

• Brand Name: CAREX WEIGHT CAPACITY 300 LB SHOWER STOOL
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): COM-DA HEALTHCARE CO. LTD / REGULATORY INSIGHT INC.
• MDR Report Key: 8760625
• MDR Text Key: 150303510
• Report Number: MW5087874
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 85