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

Catalog Number MDS86222W

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported, "her mother-in-law used the cane and was injured by a bolt sticking out of it and got 19 stitches." the mother-in-law is (b)(6), and the incident occurred approximately one month prior ((b)(6) 2021).The reporter ((b)(6), the daughter-in-law), states, "(b)(6) was walking outside, she tripped in a hole and fell, and cut her leg open." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has not been returned.Therefore, a root cause will be difficult or impossible to determine.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported, "her mother-in-law used the cane and was injured by a bolt sticking out of it and got 19 stitches.".

• Type of Device: CANE, QUAD, SMALL BASE, BLACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12467894
• MDR Text Key: 271368679
• Report Number: 1417592-2021-00166
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/14/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86222W
• Device Lot Number: J110225801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/14/2021
• 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; Required Intervention
• Patient Age: 92 YR
• Patient Weight: 54