MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS ROLLITE ROLLATOR 9153637242; WALKER, MECHANICAL

Model Number 65100

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer alleges the bolt on the wheel on the (b)(4) walker is bent.

• Brand Name: ROLLITE ROLLATOR 9153637242
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 4505731
• MDR Text Key: 5411593
• Report Number: 1531186-2015-00911
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/10/2015,02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 65100
• 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: 02/10/2015
• Distributor Facility Aware Date: 02/04/2015
• Date Report to Manufacturer: 02/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other