MAUDE Adverse Event Report: GF HEALTH PRODUCT INC. GRAHAMFIELD - GF HEALTH PRODUCTS, INC.; SET N GO WIDE HGHT ADJ. ROLLATOR

Model Number RJ4718S

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2017

Event Type  malfunction  

Event Description

Rt leg/wheel on rollator (ghp-rj4718s) broke when patient sat down.Patient not injured.Rear wheel broke off.(b)(6).

• Brand Name: GRAHAMFIELD - GF HEALTH PRODUCTS, INC.
• Type of Device: SET N GO WIDE HGHT ADJ. ROLLATOR
• Manufacturer (Section D): GF HEALTH PRODUCT INC.; grahamfield; 2935 ne pkwy.; atlanta GA 30360 2808
• MDR Report Key: 6525705
• MDR Text Key: 73917839
• Report Number: MW5069364
• Device Sequence Number: 0
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RJ4718S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 132