MAUDE Adverse Event Report: DOLOMITE AB ROLLATOR 9153651315; WALKER, MECHANICAL

Model Number FUTURA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 04/02/2015

Event Type  Injury  

Event Description

"a person walking with his walker and get help to the kitchen table.The staff turns around and hear a bang.The person then sat next to the kitchen chair and sitting on the floor.The person's sweater is stuck in the handle for lifting and lowering of the handles, see appendix upper picture.When the staff comes closer and helps the person up it is discovered that she is bleeding.A long tear in the forearm is detected.Ambulance is called and the person goes to the hospital and get sewed with thirty stitches.Everything indicates that the damage occurred at the fall and when the person is stuck in the "knob" on the walker.

Manufacturer Narrative

Should additional information become available for the patient, a supplemental record will be filed.The futura is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.

• Brand Name: ROLLATOR 9153651315
• 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: 4790204
• MDR Text Key: 18715800
• Report Number: 9615290-2015-00190
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/30/2015

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: FUTURA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/22/2015
• 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): Hospitalization