MAUDE Adverse Event Report: DOLOMITE WALK-FRAME FORIA P421B 2IN1 BLUE; WALKER, MECHANICAL

Model Number EU:P421B

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6), the device is/was also marketed and sold in the u.S.This investigation is ongoing.The device has not been returned, and no further patient information has been released.Should additional information become available, a supplemental record will be filed.

Event Description

The end-users wife reported that the bar that is used for folding the frame on the p421b walker has broken, and the end-user fell, causing a broken nose and bruises on the face.He was hospitalized.

• Brand Name: WALK-FRAME FORIA P421B 2IN1 BLUE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen 303; dio 343 7 5; SW 343 75
• Manufacturer (Section G): DOLOMITE; box 200; vaxjovagen 303; dio 343 7 5; SW 343 75
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 9494656
• MDR Text Key: 171973778
• Report Number: 9615290-2019-00005
• 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: 11/25/2019

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: EU:P421B
• Device Catalogue Number: P421B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/19/2019
• 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
• Patient Weight: 85