MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS ROLLATOR TALL ADULT M.BLUE 9153641189; WALKER, MECHANICAL

Model Number 68100-TA

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problems Fall (1848); Head Injury (1879); Pyrosis/Heartburn (1883)

Event Date 01/05/2015

Event Type  Injury  

Event Description

End user's son reported that his fathers 68100-ta rollator moved out away from him when he was sitting or about to sit.The lock on the brake handles allegedly has not been holding real good, was able to move the wheels on carpet when locked into position.Son states that his father may not be able to hear a clicking noise when locked.Son stated that his father fell backwards when the unit moved, sustained an abrasion and a gash on the head that required two staples.There was bruising and bleeding on the brain and user also sustained a collapsed lung.End user is in the head trauma unit in a hospital and then will have to go to rehab after that.He is expected to be released tentatively (b)(6) 2015.

• Brand Name: ROLLATOR TALL ADULT M.BLUE 9153641189
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 4415733
• MDR Text Key: 5163360
• Report Number: 1531186-2015-00245
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/13/2015,01/09/2015

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: 68100-TA
• 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: 01/13/2015
• Distributor Facility Aware Date: 01/09/2015
• Device Age: 19 MO
• Event Location: Other
• Date Report to Manufacturer: 01/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 90 MO
• Patient Weight: 77