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

Model Number 1037

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

(b)(6) 2015 - the dealer states one rollator had a star knob missing right out of the box.The replacement knob will be sent direct from pro basics.No further information was provided.

Manufacturer Narrative

Additional information will be added as it becomes available.

• 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 ; 1200 taylor street; elyria, OH 44036
• MDR Report Key: 4814636
• MDR Text Key: 16881479
• Report Number: 1125779-2015-00072
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/08/2015

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: 1037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 06/03/2015
• 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