MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; ROLLATOR

Catalog Number MDS86845CM

Device Problem Insufficient Information (3190)

Patient Problem Skull Fracture (2077)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

Per (b)(6) representative, witnesses stated customer was sitting on a rollator seat while her family adjusted the rollator.Customer leaned back while sitting on the rollator and fell backwards hitting her head on the floor.Customer had a loss of consciousness, for an unspecified time.Emergency services were called and customer was transported to the emergency room.(b)(6) representative stated the customer had a closed skull fracture from the fall and was admitted to the hospital for three days.Photos of the rollator were reviewed and showed a possible loose or not fully tightened adjustment knob.A root cause cannot be confirmed since the rollator has not been returned.Due to the reported skull fracture and hospital stay this medwatch is being filed.Device not returned.

Event Description

Customer fell from a rollator causing a skull fracture.

• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• Manufacturer Contact: megan debus ; one medline place; mundelein, IL 60060 ; 8476433962
• MDR Report Key: 6073619
• MDR Text Key: 58975242
• Report Number: 1417592-2016-00118
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 11/02/2016

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: No Information
• Device Catalogue Number: MDS86845CM
• Device Lot Number: 86715110010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization