MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, SUPERLIGHT, BURGUNDY

Catalog Number MDS86825SLR

Device Problem Protective Measures Problem (3015)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported that she was using the device in (b)(6) 2021 while rolling down the hallway, on a tile floor, and when she went to apply the brakes the device did not stop.Elizabeth reported that she fell over to the right side and landed on the ground on her right side.The customer reported that she could not get up by herself and she was assisted up by her family.The customer stated that she did experience pain when she fell, but she did not go to the hospital or seek medical attention at the time of the incident.The customer stated that over the next 2 days the pain increased and she had her friend take her to the emergency department where she obtained x-rays and was diagnosed with 4 fractured ribs.The customer stated that she was prescribed oxycontin for the pain and sent home the same day.No additional information is available.The sample has not been returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

The customer reported that she was using the device and while rolling down the hallway, on a tile floor, she went to apply the brakes and the device did not stop resulting in the customer falling to ground and fracturing four ribs.

• Type of Device: ROLLATOR, SUPERLIGHT, BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11400196
• MDR Text Key: 234300565
• Report Number: 1417592-2021-00032
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86825SLR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/02/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 84