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

Catalog Number 122500

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Photographs and inspection showed multiple areas of damage, appearing to be from misuse of the device.The splinters occurred from using the device after damage.

Event Description

It was reported that a radiation therapist ended up with 6 or 7 carbon fibre splinters in their hand from use of the damaged device.The splinters were removed by a nurse.

• 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: 7669121
• MDR Text Key: 113389648
• Report Number: 3010701021-2018-00001
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 08719425702056
• UDI-Public: 08719425702056
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/27/2017,06/18/2018

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: 122500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2017
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2017
• 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): Required Intervention