MAUDE Adverse Event Report: GARDEN CITY MEDICAL ROLLATOR TALL ADULT M.BLUE 9153641189; WALKER, MECHANICAL

Model Number 1037BK

Device Problem Incomplete or Missing Packaging (2312)

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

Event Type  malfunction  

Event Description

Dealer stated missing the bolt that adjusts handle out of box; no damage to the box.

Manufacturer Narrative

Should additional information become available, a supplemental record will be file.

Manufacturer Narrative

The product was returned and evaluated.The results of the return evaluation are: hardware/fasteners, height adjust knob broken/gone.

Event Description

Dealer stated missing the bolt that adjusts handle out of box; no damage to the box.

• Brand Name: ROLLATOR TALL ADULT M.BLUE 9153641189
• 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: 4813145
• MDR Text Key: 5925879
• Report Number: 1125779-2015-00065
• 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,Followup
• Report Date: 05/27/2015

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: 1037BK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2015
• 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