MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; WALKER,PALM REL,ADLT,GUARDIAN

Catalog Number G30755P

Device Problem Collapse (1099)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported by the customer that while using a walker the front wheel on the device collapsed resulting in the customer falling forward onto the ground.

Manufacturer Narrative

It was reported by the customer that while using a walker the front wheel on the device collapsed resulting in the customer falling forward onto the ground.Per the customer they were able to get back up with the assistance of his spouse with no medical attention at the time.The following morning the customer went to the hospital for further evaluation and was found to have 4 broken ribs and a bruised hand and was sent home with medication the same day.The customer received the device from (b)(6) hospital in june 2021 and uses the walker daily.The sample was not returned to the manufacturer for evaluation.No additional information is available.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.

• Type of Device: WALKER,PALM REL,ADLT,GUARDIAN
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13639414
• MDR Text Key: 286424477
• Report Number: 1417592-2022-00024
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2022

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: G30755P
• Device Lot Number: 15117030004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 93 KG