MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; TRANSPORT CHAIR

Catalog Number MDS808150E

Device Problem Insufficient Information (3190)

Patient Problem Cellulitis (1768)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

The end user's daughter reported that her father fell backwards while leaning back in the chair and hit his legs under a table.It is unknown if the brakes were engaged.He was diagnosed with cellulitis on his legs due to redness and swelling and was treated with an antibiotic.It is unknown if his skin integrity was compromised.The sample was not returned for evaluation and a root cause has not been determined.The owner's manual addresses center of gravity, balance and stability.It indicates that the center of gravity must be maintained and that the loss of proper balance may cause the transport chair to tip over.We cannot rule out user error as a potential root cause.Due to the need for medical intervention and in an abundance of caution, this medwatch is being filed.

Event Description

The end user's daughter reported that her father fell backwards while leaning back in the chair and hit his legs under a table.

• Type of Device: TRANSPORT CHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5471790
• MDR Text Key: 39423644
• Report Number: 1417592-2016-00017
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS808150E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 02/09/2016
• 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): Other
• Patient Age: 89 YR
• Patient Weight: 67