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

Device Problem Collapse (1099)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 07/01/2019

Event Type  Injury  

Event Description

According to report #mw5087874: 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 # (b)(4).

• Brand Name: CAREX WEIGHT CAPACITY 300 LB SHOWER STOOL
• Type of Device: HYGIENE ADAPTOR
• Manufacturer (Section D): COM-DA HEALTHCARE CO., LTD.; unit 3 no. 94 dongcheng road; dong sheng town; zhong shan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO., LTD.; unit 3 no. 94 dongcheng road; dong sheng town; zhong shan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 8810001
• MDR Text Key: 151705144
• Report Number: 3014644996-2019-00001
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/20/2019

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 07/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention