MAUDE Adverse Event Report: GARDEN CITY MEDICAL DOLOMITE MAXI ROLLATOR 650 7331492560417; WALKER, MECHANICAL

Model Number 1033

Device Problem Bent (1059)

Patient Problems Dyspnea (1816); Shock (2072); Complaint, Ill-Defined (2331)

Event Date 12/25/2013

Event Type  malfunction  

Event Description

It was reported that the end user was utilizing his 1033 probasics bariatric rollator on a walkway when the wheels and metal frame bent.User sustained aggravation to his myocardial infarction, shortness of breath as well as a severe shock to his nervous system.No alleged medical intervention.

• Brand Name: DOLOMITE MAXI ROLLATOR 650 7331492560417
• 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: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4390514
• MDR Text Key: 5431313
• Report Number: 1125779-2014-00004
• 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: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 01/07/2015
• 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