MAUDE Adverse Event Report: MEDTEC, INC. (CIVCO) TYPE-S HEAD, NECK & SHOULDER THERMOPLASTIC; HOLDER, HEAD, RADIOGRAPHIC

Catalog Number MTAPSD2.4

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

Thermoplastic masks broke, four in a row, when used for ct simulation (prep for radiation therapy).Fifth one did not break and was able to be molded without problem.So delay in completing patient procedure.

• Brand Name: TYPE-S HEAD, NECK & SHOULDER THERMOPLASTIC
• Type of Device: HOLDER, HEAD, RADIOGRAPHIC
• Manufacturer (Section D): MEDTEC, INC. (CIVCO); 1401 8th st. s.e.; orange city IA 51041
• MDR Report Key: 6915905
• MDR Text Key: 88252601
• Report Number: 6915905
• Device Sequence Number: 1
• Product Code: IWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2017,09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MTAPSD2.4
• Device Lot Number: M931770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1