MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; CRUTCH

Device Problem Naturally Worn (2988)

Patient Problem Injury (2348)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that an end user fractured his ankle on (b)(6) 2015 and was provided a pair of crutches for ambulation.On (b)(6) 2015, while ambulating in his kitchen, the rubber tip of one of the crutches apparently wore through and he fell.It was reported that he suffered "a torn bicep and that the injury required surgery to reattach the ligament".We have no item number or lot number.There is no sample or photos to evaluate.We had not previously been made aware of this incident.No other details were provided to us.We have not confirmed the issue or identified a root cause.However, in an abundance of caution, due to the reported injury and need for surgical intervention, this medwatch is being filed.Device not returned.

Event Description

The end user fell when the crutch tip wore through and suffered a torn bicep.

• Type of Device: CRUTCH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5908521
• MDR Text Key: 53301203
• Report Number: 1417592-2016-00090
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/26/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention