MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. WALKER

Catalog Number G30755P

Device Problem Break (1069)

Patient Problem Cyst(s) (1800)

Event Date 01/11/2014

Event Type  Injury  

Event Description

The front leg of the walker broke, the end user fell and was diagnosed with a ganglion cyst of his left wrist.

Manufacturer Narrative

The end user reported that the front left leg of the walker broke and he fell, suffering a ganglion cyst of his left wrist.He states the walker was one year old.He did not return the sample for eval and no lot number was provided to us.Photos provided by the end user showed a full fracture on one left of the product, and a partial fracture on another leg of the product.It could not be confirmed by the evidence provided whether the front or rear legs of the sample had fractured.The partial fracture was indicative of the walker leg being bent inwards.Further info or a physical sample is necessary to determine the root cause of the incident.There were no photos of the entire device and we have not been able to confirm the identity.

• Brand Name: WALKER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 3649406
• MDR Text Key: 4314595
• Report Number: 1417592-2014-00015
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2014

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: G30755P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/21/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 9