MAUDE Adverse Event Report: GARDEN CITY MEDICAL TALL ADULT WALKLITE WALKER 9153643781; WALKER, MECHANICAL

Model Number 1030KW

Device Problems Bent (1059); Mechanical Problem (1384); Out-Of-Box Failure (2311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4) the provider states out of the box, the locking mechanism is bent inward and cannot be assembled.This is an out of box failure from order number (b)(4).The provider states the unit never reach an end user and protocol questions do not apply.He also states the shipping carton was intact 7857hf.

• Brand Name: TALL ADULT WALKLITE WALKER 9153643781
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GARDEN CITY MEDICAL; 15 s. main st.; pmi - probasics - pinnacle; marlboro NJ 07746
• Manufacturer (Section G): GARDEN CITY MEDICAL; 15 s. main st.; pmi - probasics - pinnacle; marlboro NJ 07746
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4637335
• MDR Text Key: 5596485
• Report Number: 1125779-2015-00023
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1030KW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/27/2015
• 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