MAUDE Adverse Event Report: CEFENDY HEALTHCARE S33 SHOWER CHAIR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Physical Entrapment (2327)

Event Date 07/01/2015

Event Type  Injury  

Event Description

Whilst sitting on the shower chair in the shower, a testicle dropped through one of the drainage holes in the seat and got trapped underneath.The user could not get up from the chair as the testicle had swollen and staff were unable to free it from the chair.The fire brigade and ambulance were contacted.The fire brigade were unable to free the user and therefore he was taken to the hospital in the chair and the chair was removed at the hospital.No other treatment was required.

• Brand Name: S33 SHOWER CHAIR
• Type of Device: S33
• Manufacturer (Section D): CEFENDY HEALTHCARE
• MDR Report Key: 4905831
• MDR Text Key: 6538108
• Report Number: MW5043948
• Device Sequence Number: 1
• Product Code: ILS
• Reporter Country Code: UK
• 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: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 60