MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE; ROLLATOR

Model Number 171

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 06/16/2016

Event Type  Injury  

Event Description

(b)(4) received notice regarding the incident from enduser's niece, involving a rollator, a product imported and distributed by (b)(4).The rollator allegedly broke at the weld causing the enduser to cut herself.She went to the hospital and received 7 stitches.Due to lack of product information, we were unable to identify the manufacturer of the product.(b)(4) is in the process of retrieving the alleged product for evaluation.This report is based on the information that was provided by the enduser's niece.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Type of Device: ROLLATOR
• MDR Report Key: 5798725
• MDR Text Key: 49688531
• Report Number: 2438477-2016-00033
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/15/2016,06/16/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 171
• 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: 07/15/2016
• Distributor Facility Aware Date: 06/16/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention