MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CRUTCH

Catalog Number MDS50514-10

Device Problem Naturally Worn (2988)

Patient Problem Damage to Ligament(s) (1952)

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

The end user fractured his left tibia on (b)(6) 2016 and was given crutches for ambulation.He was ambulating on various surfaces both inside and outside of his home.He states that on (b)(6), while ambulating in his home, the crutch tip wore through and he fell.He was evaluated by his physician the following day and was told he tore a ligament in his left leg below his tibia.The torn ligament will require surgical repair.The sample was not returned for evaluation.We have no photos of the device.At root cause has not been determined.Due to the reported injury, a medwatch is being filed.

Event Description

Crutch tip wore through, end user fell suffering a torn ligament.

• 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: 5894974
• MDR Text Key: 52724958
• Report Number: 1417592-2016-00085
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/22/2016

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
• Device Catalogue Number: MDS50514-10
• Device Lot Number: 74716020004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• 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: 26 YR
• Patient Weight: 86