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

Catalog Number MDS86222CHR

Device Problem Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, his left foot "got caught on the floor" and the rubber on the bottom of the cane "fell off" causing him to fall "sideways into the counter".The customer reported when it's hot outside the rubber bottom "loosens" and causes the rubber bottom to fall off.The customer reported when he fell into the counter, his top teeth were "knocked out" and his bottom teeth were "pushed forward and backward out of place".The customer reported he went to his physician who manually pushed the bottom teeth back into the gum and applied pressure to stop the gums from bleeding.The customer reported his gums continued to bleed and he required an emergency room visit where more pressure was applied to stop the bleeding.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 left foot "got caught on the floor" and the rubber on the bottom of the cane "fell off" causing him to fall "sideways into the counter".

• Type of Device: CANE, QUAD, SMALL BASE, CHROME
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17785283
• MDR Text Key: 323876532
• Report Number: 1417592-2023-00378
• Device Sequence Number: 1
• Product Code: IPS
• 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: 09/20/2023

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 Number: MDS86222CHR
• Device Lot Number: 15122080001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/20/2023
• 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