MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; G2-102KX4

Catalog Number G2-102KX4

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 02/14/2024

Event Type  Injury  

Event Description

According to the customer on 02/14/24 the user was sitting on the chair when the "right back leg of the chair broke off and the chair collapsed.".

Manufacturer Narrative

According to the customer on 02/14/24 the user was sitting on the chair when the "right back leg of the chair broke off and the chair collapsed".Per the customer family members were able to assist the user back to their feet and into a chair.Per customer the user has been icing his knee and taking unspecified pain medications as they had their knee replaced on (b)(6) 2024.According to the customer the user experienced drainage and an infection related to the fall.Per customer the user was given antibiotics and given specific cleaning and bandaging instructions.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: G2-102KX4
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093 ; 8479492650
• MDR Report Key: 18886104
• MDR Text Key: 337442343
• Report Number: 1417592-2024-00151
• Device Sequence Number: 1
• Product Code: ILS
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: G2-102KX4
• Device Lot Number: 94823110001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other