MAUDE Adverse Event Report: GARDEN CITY MEDICAL ROLLATOR ADULT MIDNIGHT BLUE 9153641187; WALKER, MECHANICAL

Model Number 1033MARBL

Device Problem Crack (1135)

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

Event Type  malfunction  

Event Description

The dealer states that out of the box, one of the caster wheels has a small crack in it.

Manufacturer Narrative

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

Manufacturer Narrative

The device was evaluated by the returns department which found that the plastic was broken around right front caster.

Event Description

The dealer states that out of the box, one of the caster wheels has a small crack in it.

• Brand Name: ROLLATOR ADULT MIDNIGHT BLUE 9153641187
• 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: 4878124
• MDR Text Key: 5867664
• Report Number: 1125779-2015-00127
• 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,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/03/2015

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: 1033MARBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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