MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS ROLLATOR ADULT RED 9153641186; WALKER, MECHANICAL

Model Number 65100R

Device Problem Break (1069)

Patient Problems Abrasion (1689); Fall (1848); Discomfort (2330)

Event Date 05/21/2014

Event Type  Injury  

Event Description

It has been reported by an end user that the front wheel on a 65100r rollator broke in two at the top of the wheel, and caused him to fall to the floor.The end user stated his left arm is scratched up and has a sore back.

• Brand Name: ROLLATOR ADULT RED 9153641186
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 4462142
• MDR Text Key: 5398033
• Report Number: 1531186-2015-00649
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2015,05/22/2014

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: 65100R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2015
• Distributor Facility Aware Date: 05/22/2014
• Date Report to Manufacturer: 01/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 127