MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WHEELCHAIR, FREEDOM CHAIR,19"WIDE,RE

Catalog Number MDS808200SLR

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that while end-user was transferring from bed to transport chair, the brake of the transport chair did not secure resulting in end-user falling.The end-user reportedly hit her face onto laminated flooring and sustained a laceration to the eyebrow area, which required five stitches to close.Reportedly, at the time of the incident, emergency medical services was called and patient was taken to an emergency department.It was also reported that patient required unspecified x-rays and there was "nothing broken".The transport chair involved in this incident was used for approximately one year prior to this incident.Due to the reported incident and the required medical intervention, this medwatch is being filed.The sample has not been returned for evaluation.A root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that while end-user was transferring from bed to the transport chair, the brake of the transport chair did not secure resulting in the end- user falling and sustaining a laceration to the eyebrow area.

• Type of Device: WHEELCHAIR, FREEDOM CHAIR,19"WIDE,RE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9410514
• MDR Text Key: 190758687
• Report Number: 1417592-2019-00217
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS808200SLR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 58