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

Catalog Number MDS808200SLBR

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/28/2016

Event Type  Injury  

Manufacturer Narrative

The end user was being pushed in the chair outside and the chair hit a crack in a parking lot.One of the handles on the chair broke.The end user's daughter reported that her mother fell suffering 3 fractured fingers and a minor cut on her forehead.The sample has not been returned for evaluation and photos were not provided.Care, maintenance and overall condition of the chair is unknown.It is unknown if the seat belt was being used.It states in the user's manual that the use of the seat belt is recommended.A root cause has not been determined.However, due to the reported injury, this medwatch is being filed.

Event Description

The end user was being pushed in the chair outside and the chair hit a crack in a parking lot.One of the handles on the chair broke.

• 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: 5547901
• MDR Text Key: 41895170
• Report Number: 1417592-2016-00031
• 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: Other
• Type of Report: Initial
• Report Date: 04/05/2016

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?: No
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: MDS808200SLBR
• Device Lot Number: U140707281
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 88 YR
• Patient Weight: 64