MAUDE Adverse Event Report: DOLOMITE ROLLATOR FUTURA-520 BLACK W BASKET TRAY; WHEELCHAIR, MECHANICAL

Model Number FUTURA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Invacare was made aware of this event that occurred in (b)(6) involving a futura rollator.Invacare is filing this report because the device is also marketed and sold in the u.S.It is not known, if the wheel fell off before the incident took place or if the patient falling on it caused it to fall off.The rollator was around 8 years old at the time of the incident and had therefore already exceeded its expected service life.The expected service life of this product is five years when used in accordance with the safety instructions, maintenance intervals and correct use, stated in the user manual.The effective product life cycle can vary according to frequency and intensity of use.Should additional information become available, a supplemental record will be filed.

Event Description

Front wheel fell off of the futura rollator and the use fell.It is not known if the wheel fell off before or as a result of the fall.The user fell and sustained a head injury, and required stitches.

• Brand Name: ROLLATOR FUTURA-520 BLACK W BASKET TRAY
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): DOLOMITE; box 200; växjövägen 303, diö ; SW
• Manufacturer (Section G): DOLOMITE; växjövägen 303; box 200; dio, sweden 34375 ; SW 34375
• Manufacturer Contact: jason fiest ; one invacare way; 8003336900
• MDR Report Key: 12331641
• MDR Text Key: 266907197
• Report Number: 9615290-2021-00001
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: FUTURA
• Device Catalogue Number: FUTURS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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): Required Intervention
• Patient Age: 67 YR