MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; WHEELCHAIR,K1,18",SB DLA,ELR FOOT

Catalog Number K1186N22E

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Damage to Ligament(s) (1952)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, his mother was transferring into the wheelchair from the bed and fell onto her "knee and face".The customer reported the "leg extension" was locked and unable to be moved out of the way causing his mother to "trip on the leg extension".The customer reported his mother went to the hospital where an "mri of the knee" was performed and showed "knee effusions and a meniscus tear".According to the customer, his mother has arthritis of the knee and the orthopedic surgeon "could not confirm" if the tear was a result of the fall or a pre-existing condition.The customer reported his mother is required to have a "total knee replacement surgery" and is taking over-the-counter "tylenol" for pain.Sample requested for return evaluation it has been determined that the reported event caused or contributed to serious injury, therefore, 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, his mother was transferring into the wheelchair from the bed and fell onto her "knee and face".

• Type of Device: WHEELCHAIR,K1,18",SB DLA,ELR FOOT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17401004
• MDR Text Key: 319832320
• Report Number: 1417592-2023-00318
• Device Sequence Number: 1
• Product Code: IOR
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: K1186N22E
• Device Lot Number: 16422100002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2023
• 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