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

Catalog Number 122500

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348)

Event Date 11/27/2017

Event Type  Injury  

Event Description

Three (3) persons (health-care professionals) obtained carbon fibre splinters in their hands during the use of the device.In the case of one person, this resulted in minor inflammatory reactions.The injured persons did not require any medical intervention.

• Brand Name: BREASTBOARD LX
• 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.; kouwe hoek 18; waddinxveen 2741 PX; NL 2741 PX
• Manufacturer Contact: j. drenth ; kouwe hoek 18; waddinxveen, 2741 -PX ; NL 2741 PX
• MDR Report Key: 7669123
• MDR Text Key: 113393579
• Report Number: 3010701021-2018-00003
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 08719425702056
• UDI-Public: 08719425702056
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/20/2018

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: 122500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other