MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP WALKER,PADDLE,FOLDING, 5" WHEELS, BLUE

Catalog Number MDS86410KDBW

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Laceration(s) (1946)

Event Date 07/14/2022

Event Type  Injury  

Event Description

It was reported that the customer was coming down stairs and the cables came out from where the leg is on the walker resulting in the customer losing her balance and falling to the ground.The customer sustained a laceration to her head and required 4 staples.

Manufacturer Narrative

It was reported that the customer was coming down stairs and the cables came out from where the leg is on the walker resulting in the customer losing her balance and falling to the ground.The customer stated that she was with her son and brother and was able to get up and go to the hospital for evaluation.The customer received a ct scan which was shown to be unremarkable and required 4 stapes to a laceration that she sustained on her head.The customer stated that aside from staple removal she was informed that no additional follow up is needed.The sample has not been returned to the manufacturer for evaluation.No additional information is available.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.

• Brand Name: WALKER,PADDLE,FOLDING, 5" WHEELS, BLUE
• Type of Device: WALKER,PADDLE,FOLDING, 5" WHEELS, BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15136760
• MDR Text Key: 296948874
• Report Number: 1417592-2022-00127
• 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: 07/30/2022

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: MDS86410KDBW
• Device Lot Number: 15117070002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 07/30/2022
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 120 KG