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

Model Number 1033MAR

Device Problems Crack (1135); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Provider states that out of the box the left brake was physically cracked therefore causing that brake to not function.

Manufacturer Narrative

Device returned for evaluation.Engineering report states- new out of box, plastic broken at left handle.

• 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: 4878111
• MDR Text Key: 6060205
• Report Number: 1125779-2015-00126
• 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: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1033MAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• 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