MAUDE Adverse Event Report: MACROMEDICS BV DSPS; PATIENT POSITIONING DEVICE

Catalog Number 114510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made by email and telephone to gather more information about the event from the complainant and initial reporter.Any missing information in this report is due to the failure of the initial reporter to reply to these attempts.The investigation is ongoing.There is no evidence of device malfunction or confirmed evidence of harm.The complaint is under investigation.

Event Description

It was reported that two patients obtained skin reactions in the area where the radiation beam passes through the treatment couch, the cradle (part of the device) and the rim of the mask.There is no evidence of device malfunction or confirmed evidence of harm.The complaint is under investigation.

• Brand Name: DSPS
• Type of Device: PATIENT POSITIONING DEVICE
• Manufacturer (Section D): MACROMEDICS BV; kouwe hoek 18; waddinxveen, 2741 PX; NL 2741 PX
• Manufacturer Contact: jaap drenth ; kouwe hoek 18; waddinxveen; NL 2741 PX
• MDR Report Key: 7749900
• MDR Text Key: 116044198
• Report Number: 3010701021-2018-00004
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K142420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114510
• Device Lot Number: NOT YET KNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other