MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Guardian; WHEELCHAIR, K3, 16", SB DDLA, SA FOOT

Model Number	K3166N24S
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on (b)(6) 2022 her mother was riding in the car and when attempting to get out and sit in the wheelchair a 'rough piece of metal on the wheelchair gauged a deep wound on the lower right leg'.Per the customer they were already at a hospital visiting the customer's father and the wound was dressed by a nurse with gauze and a bandage who happened to notice the injury.Per the customer the wound did not heal after 2 weeks and they went to an urgent care where imaging was performed, which came back negative, and she was referred to receive 'advanced wound care and ordered home health starting on (b)(6) 2022 until the wound was better'.Per the customer her mother has been receiving wound care from home health 3 times a week and the wound is reported to be healing and doing better.No additional information is available.The device is available and has been requested to be returned 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 or Problem Description
According to the customer on (b)(6) 2022 her mother was riding in the car and when attempting to get out and sit in the wheelchair a 'rough piece of metal on the wheelchair gauged a deep wound on the lower right leg'.Per the customer the injury required multiple wound care visits and home health.

• Brand Name: Guardian
• Common Device Name: WHEELCHAIR, K3, 16", SB DDLA, SA FOOT
• 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: 15256298
• Report Number: 1417592-2022-00142
• Device Sequence Number: 15133623
• Product Code: IOR
• UDI-Device Identifier: 00193489087126
• UDI-Public: 00193489087126
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: K3166N24S
• Device Catalogue Number: K3166N24S
• Device Lot Number: 16421120001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 55 KG