MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS ROLLATOR ADULT MIDNIGHT BLUE 9153641187; WALKER, MECHANICAL

Model Number 68100

Device Problem Break (1069)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Event Description

It was reported that the release paddle on a 68100 rollator broke.The end users husband sustained a cut on the sharp edge requiring 10 stitches.

• Brand Name: ROLLATOR ADULT MIDNIGHT BLUE 9153641187
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 4705641
• MDR Text Key: 5720281
• Report Number: 1531186-2015-01028
• 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: 04/20/2015,04/15/2015

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
• 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: 04/20/2015
• Distributor Facility Aware Date: 04/15/2015
• Device Age: 54 MO
• Date Report to Manufacturer: 04/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention