MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CRUTCH,ALUMINUM,ADULT,TALL,LF,300LB

Catalog Number MDSV80534

Device Problem Torn Material (3024)

Patient Problem Injury (2348)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the tip of a crutch ripped during use resulting in the customer falling, damaging his achilles tendon and requiring surgery.The customer reported that he initially had an achilles tendon injury on (b)(6) 2017 and was given the crutches at the hospital.On (b)(6) 2017 the customer reported that he was trying to stand up using the crutches and the crutch slipped out from under him resulting in the customer falling on the hardwood floor.Per the customer, after an mri evaluation he underwent surgery for the repair of a re-ruptured achilles tendon.The customer reported that he currently does not use any assistive device and he is walking independently.The sample was returned for evaluation.Upon investigation of the device, the sample was found to be in used condition.One crutch had the adjustable crutch leg protruding through the center of the bottom face of the tip.It is not known if the device caused or contributed to the fall; however the customer reported issue of a ripped crutch tip was confirmed.A root cause has not been determined.Due to the reported incident and subsequent need for surgical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the tip of a crutch ripped during use.

• Type of Device: CRUTCH,ALUMINUM,ADULT,TALL,LF,300LB
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7307434
• MDR Text Key: 101312571
• Report Number: 1417592-2018-00010
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDSV80534
• Device Lot Number: 74717060002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 84