MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRANSPORT CHAIR,ALUM, BASIC,12" WHL

Catalog Number MDS808210ARE

Device Problem Collapse (1099)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the back part of the transport chair collapsed and customer experienced a fall resulting in a fracture of the left forearm.The customer's daughter reported that the customer was sitting in a locked transport chair when the back part of the chair collapsed on itself resulting in the customer falling on her back left side and fracturing her left forearm.The customer was on vacation and was taken to a local clinic where an x-ray was performed and confirmed a fracture to the left forearm.No additional diagnostic imaging was reported.The customer required surgical intervention to set the reported fracture.The transport chair involved in the incident was reportedly discarded and is not available to be returned for evaluation.Due to the reported incident and the need for surgical intervention, this medwatch is being filed.In the even that additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the back part of the transport chair collapsed and customer experienced a fall resulting in a fracture of the left forearm.

• Type of Device: TRANSPORT CHAIR,ALUM, BASIC,12" WHL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7271438
• MDR Text Key: 100117481
• Report Number: 1417592-2018-00008
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS808210ARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 66