MAUDE Adverse Event Report: DOLOMITE AB DOLOMITE LEGACY 600 ROLLATOR WITH BASKET; WALKER, MECHANICAL

Model Number JAZZSTD

Device Problems Bent (1059); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Right rear fork bent, wheel angled inward.

Manufacturer Narrative

The return evaluation documented by the (b)(4) returns department is defined as: frame/structure, frame bent.This confirms the alleged issue.

Event Description

Right rear fork bent, wheel angled inward.

• Brand Name: DOLOMITE LEGACY 600 ROLLATOR WITH BASKET
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE AB; vaxjovagen 303; dio ; SW
• Manufacturer (Section G): DOLOMITE AB; vaxjovagen 303; dio ; SW
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5110458
• MDR Text Key: 27177294
• Report Number: 9615290-2015-00286
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Followup
• Report Date: 09/17/2015

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: JAZZSTD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• 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