• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CANE, OFFSET, BLACK, ALUMINUM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDLINE INDUSTRIES LP; CANE, OFFSET, BLACK, ALUMINUM Back to Search Results
Catalog Number MDS86420
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Concussion (2192)
Event Date 12/31/2023
Event Type  Injury  
Event Description
According to the customer, the metal has pierced through the "rubber cap" at the bottom of the cane, causing the cane to slide, and him to fall "multiple times".
 
Manufacturer Narrative
According to the customer, the metal has pierced through the "rubber cap" at the bottom of the cane, causing the cane to slide, and him to fall "multiple times".The customer reported he has gone to the emergency room where he was diagnosed with a concussion after a "scan showed swelling on the brain".The customer reported he left the hospital "against medical advice", did not receive treatment for the "concussion", and did not follow up with another provider.This writer advised the customer to stop using the cane.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.
 
Manufacturer Narrative
Investigation conclusions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
CANE, OFFSET, BLACK, ALUMINUM
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
danielle tognocchi
three lakes dr
northfield, IL 60093
MDR Report Key18601489
MDR Text Key334002178
Report Number1417592-2024-00040
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,Followup
Report Date 04/09/2024
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 NumberMDS86420
Device Lot Number88522030002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/01/2024
Initial Date FDA Received01/29/2024
Supplement Dates Manufacturer Received03/11/2024
Supplement Dates FDA Received04/09/2024
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;
-
-