MAUDE Adverse Event Report: MACROMEDICS B.V. OMNIBOARD; PATIENT POSITIONING BASEPLATE

Catalog Number 126120

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

A copy of the patient's treatment plan was received.It was apparent that the device and its inhomogeneous parts (specifically the delrin inserts) were not sufficiently taken into account in the dose-planning.This caused high build-up effects, resulting in the skin irritation.The device was not returned for evaluation as there was no device damage or malfunction.

Event Description

The patient experienced skin irritation during radiation therapy.They were treated on the omniboard device.The patient did not require medical intervention on account of the irritation.

• Brand Name: OMNIBOARD
• Type of Device: PATIENT POSITIONING BASEPLATE
• Manufacturer (Section D): MACROMEDICS B.V.; kouwe hoek 18; waddinxveen 2741 PX; NL 2741 PX
• Manufacturer (Section G): MACROMEDICS B.V.; NL
• Manufacturer Contact: j. drenth ; kouwe hoek 18; waddinxveen, 2741 -PX ; NL 2741 PX
• MDR Report Key: 7669219
• MDR Text Key: 113392592
• Report Number: 3010701021-2018-00002
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 126120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other