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

Catalog Number	122500
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: PATIENT POSITIONING BASEPLATE
• Manufacturer (Section D): MACROMEDICS B.V.; kouwe hoek 18; waddinxveen 2741 PX; NL 2741 PX
• MDR Report Key: 7669123
• Report Number: 3010701021-2018-00003
• Device Sequence Number: 806249
• Product Code: IYE
• UDI-Device Identifier: 08719425702056
• UDI-Public: 08719425702056
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 122500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other