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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CANE, QUAD, SMALL BASE, BLACK

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MEDLINE INDUSTRIES, LP; CANE, QUAD, SMALL BASE, BLACK Back to Search Results
Catalog Number MDS86222W
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/19/2023
Event Type  Injury  
Event Description
According to the customer on (b)(6) 2023 her mother was using her cane to ambulate in the house "when the rubber end came off one of the legs at the bottom of the cane and she lost her balance and fell to the floor".
 
Manufacturer Narrative
According to the customer on (b)(6) 2023 her mother was using her cane to ambulate in the house "when the rubber end came off one of the legs at the bottom of the cane and she lost her balance and fell to the floor".Per the customer she contacted the paramedics as she was unable to get her mother up by herself.Per the customer her mother was experiencing pain and discomfort post fall as well as a sharp decrease in range of motion on her right arm.Per the customer she took her mother to the hospital the following day where an x-ray was performed which confirmed a fracture of her mother's right humerus.No additional information is available at this time.The sample has not been returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
 
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Type of Device
CANE, QUAD, SMALL BASE, BLACK
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key16538420
MDR Text Key311238898
Report Number1417592-2023-00100
Device Sequence Number1
Product Code IPS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/14/2023
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
Device Operator Lay User/Patient
Device Catalogue NumberMDS86222W
Device Lot Number15119110001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/21/2023
Initial Date FDA Received03/14/2023
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 Number1
Patient Outcome(s) Other;
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