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

Model Number 12050-37-86VA

Device Problem Break (1069)

Patient Problems Death (1802); Fall (1848); Hip Fracture (2349)

Event Date 12/23/2015

Event Type  Death  

Manufacturer Narrative

No return anticipated, as the end users daughter declined to return the rollator.There is insufficient information regarding whether there was a malfunction or physical damage from the end user using the rollator while pedaling a stationary bicycle; therefore an mdr will be filed.Multiple attempts have been made for additional information.Photographs and serial number have been requested.Should additional information should become available, this record will be updated accordingly.

Event Description

The consumers daughter states her father received the rollator from the va 4-6 years ago.The daughter states her father was informed by the va that he could exercise by sitting on the walker backwards and use a pedal bike for exercise.On (b)(6) 2015 while using the walker as specified, the wheel on the walker broke off.The daughter alleged her father flew back and landed on his hip fracturing it.The daughter alleged her father had to have surgery and alleged this event led to the consumers eventual death on (b)(6) 2016.The daughter states she has the walker still and can send pictures and proof of his surgery.Update from consumer affairs on 7/28/16: end users daughter called back and said that she will email photos of the walker but will not return it.She said the va was notified and has advised their staff not to tell patients to use their walker or rollator in this manner anymore and have changed the way they do therapy and use the products.No further information was provided.

• Brand Name: DOLOMITE LEGACY 600 ROLLATOR WITH BASKET
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5892893
• MDR Text Key: 52620028
• Report Number: 9616091-2016-01173
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/25/2016

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: 12050-37-86VA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/22/2016
• 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): Death
• Patient Age: 90