MAUDE Adverse Event Report: COMPASS HEALTH BRANDS (CORPORATE OFFICE) CAREX HEALTH PRODUCTS BATH AND SHOWER SEAT; ADAPTOR, HYGIENE

Model Number B65100

Device Problems Break (1069); Structural Problem (2506)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/15/2019

Event Type  Injury  

Event Description

The family was vacationing in (b)(6).The subject was showering.The back right leg of the shower seat in question lost its shape and the individual using the chair landed on his back on the floor between the toilet and shower.Paramedics were called since the subject has limited mobility and professional help is necessary.He was taken to beebe (b)(6) center in (b)(6) by the paramedics who determined that due to his condition, he should be seen by medical professionals.The determination there was that one of his fingers had two or three fractures.It was splinted and iced.His wife was given instructions to take him to an orthopedic specialist in (b)(6) when we got home.This was done and on august 27, out-patient surgery was performed, straightening the finger and securing it with pins.The surgeon indicated that without the surgery, (b)(6)' s hand would be deformed.

• Brand Name: CAREX HEALTH PRODUCTS BATH AND SHOWER SEAT
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): COMPASS HEALTH BRANDS (CORPORATE OFFICE)
• MDR Report Key: 9076143
• MDR Text Key: 159044754
• Report Number: MW5089837
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/05/2019

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
• Device Model Number: B65100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 104