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

Catalog Number MDS808200SLSR

Device Problem Unintended Movement (3026)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Injury (2348)

Event Date 10/31/2014

Event Type  Injury  

Event Description

The end user was being pushed while sitting in the wheelchair and fell backwards, hitting his head on the floor.

Manufacturer Narrative

The end user fell backward while being pushed by his caregiver.The caregiver indicated the incident occurred when the left push handle broke at the folding mechanism.He suffered a small head laceration and hematoma.The laceration was repaired with four staples.The end user was hospitalized overnight for observation and by the next day it was noted that the hematoma had diminished considerably.He was diagnosed with a vertebrae fracture for which he was diagnosed with a vertebrae fracture for which he was discharged with a cervical collar.The sample was returned and evaluated.Both push handle ends exhibited damage indicative of a previous impact.A root cause has not been determined.We cannot rule out the possibility that the damage indicative of a previous impact.A root cause has not been determined.We cannot rule out the possibility tha the dame to the left push handle was the result of an impact rather than the cause of the incident.No manufacturing defect was found during the sample evaluation.

• Brand Name: TRANSPORT CHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4346122
• MDR Text Key: 16989938
• Report Number: 1417592-2014-00113
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: MDS808200SLSR
• Device Lot Number: B120805636
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 76