MAUDE Adverse Event Report: MAXHEALTH CORP. BARIATRIC ROLLATOR

Model Number 30196

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

A nurse called in, stating a patient who is blind was cut on the palm of her right hand from a sharp plastic piece under the right brake handle on a rollator.There was no medical attention necessary, but the wound was cleaned and a band-aid was put on it.The event is reported as having occurred on wood flooring.

• Brand Name: BARIATRIC ROLLATOR
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, n/a 221 ; TW 221
• MDR Report Key: 6455064
• MDR Text Key: 71576702
• Report Number: 3012316249-2017-00037
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/03/2017

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: 30196
• Device Catalogue Number: 30196
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2017
• Distributor Facility Aware Date: 03/01/2017
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 04/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 128