MAUDE Adverse Event Report: PROBASICS; ROLLATOR

Model Number RLA8BG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

Patient contacted the location and advised she had two surgeries due to cutting her ankle on a rollator and being diabetic.She had previously reported she did not cut her leg, but did not like the rollator delivered to her.Junior rollator was delivered to her (b)(6) 2019.Report states date of incident was (b)(6) 2019 but then states the rollator was delivered to her on (b)(6) 2019.Supplier/manufacturer is unknown due to this device was manufactured before (b)(6)'s acquisition of probasics.

• Brand Name: PROBASICS
• Type of Device: ROLLATOR
• MDR Report Key: 9465801
• MDR Text Key: 179611373
• Report Number: 3012316249-2019-00042
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2019

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: No Information
• Device Model Number: RLA8BG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2019
• Distributor Facility Aware Date: 11/22/2019
• Device Age: 54 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization