MAUDE Adverse Event Report: CAROLINA CAROLINA ORCHESTRA TREATMENT CHAIR; CHAIR, EXAMINATION AND TREATMENT

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

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 09/23/2019

Event Type  malfunction  

Event Description

Pt attempting to engage foot pedal break on a carolina orchestra chair with only a thick sock like footwear on causing open laceration wounds noted to the plantar aspects of right digits 2, 3 and 4 in the proximal sulcus with active bleeding, 12mm in length in transverse direction with 2mm gapping wounds- requiring 12 sutures - also a multiple foot fractures.There are no sharp edges on the pedal but it is difficult to engage and requires force.

• Brand Name: CAROLINA ORCHESTRA TREATMENT CHAIR
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• Manufacturer (Section D): CAROLINA
• MDR Report Key: 9141073
• MDR Text Key: 160920938
• Report Number: MW5090124
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 118