MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; WALKER,2 BUTTON,W/5INWHEELS,BASIC, EACH

Catalog Number MDS86410W54BH

Device Problems Collapse (1099); Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer, her mother, was walking with the device and the rivet fell out of the walker which caused the walker to collapse.The customer stated that the bolts fell out of the arm and her mother fell to the ground.The paramedics were called and the mother was taken to the hospital where she received approximately 40 stitches between the cut in her leg and the cut in her arm.The customer stated that she now has a wound care nurse come to the house 3 days a week for the injury.The customer also stated that her mother has a bridge in her mouth that is now loose due to the fall.The mother was treated at the hospital and released home.The device is available and has been requested to be returned 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.

Event Description

According to the customer, her mother, was walking with the device and the rivet fell out of the walker which caused the walker to collapse.Mother received 40 stitches.

• Type of Device: WALKER,2 BUTTON,W/5INWHEELS,BASIC, EACH
• 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: 14189903
• MDR Text Key: 289949796
• Report Number: 1417592-2022-00058
• 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: 04/22/2022

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: MDS86410W54BH
• Device Lot Number: 88517060009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 59 KG