MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CRUTCH,QUICK-FIT,4' 7"-6' 7",WALMART

Catalog Number WAL80540

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Report received by (b)(6) on (b)(6) 2020 in which a customer identified as (b)(6) reports her son (b)(6) (end user) had fallen and hurt himself while using equate universal crutches.(b)(6) reports, "it broke and snapped in half causing (b)(6) to fall." (b)(6) reports, end user was taken to the hospital where he received an unknown number of stitches.(b)(6)further reports the end users broke his television in the fall.The crutches are not available for return and evaluation.Due to the reported nature of the incident and in abundance of caution, this medwatch is being filed.No additional details are available related to the customer reported issue.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported while end user was using equate universal crutches, "it broke and snapped in half causing end user to fall and hurt himself.

• Type of Device: CRUTCH,QUICK-FIT,4' 7"-6' 7",WALMART
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 10623179
• MDR Text Key: 210593831
• Report Number: 1417592-2020-00105
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: WAL80540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• 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): Required Intervention