MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for TYPE-S HEAD, NECK & SHOULDER THERMOPLASTIC MTAPSD2.4 manufactured by Medtec, Inc. (civco).
[88252600]
Patient Sequence No: 1, Text Type: N, H10
[88252601]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6915905 |
| MDR Report Key | 6915905 |
| Date Received | 2017-10-05 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-05-31 |
| Report Date | 2017-08-15 |
| Date Reported to FDA | 2017-08-15 |
| Date Reported to Mfgr | 2017-08-15 |
| Date Added to Maude | 2017-10-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYPE-S HEAD, NECK & SHOULDER THERMOPLASTIC |
| Generic Name | HOLDER, HEAD, RADIOGRAPHIC |
| Product Code | IWY |
| Date Received | 2017-10-05 |
| Catalog Number | MTAPSD2.4 |
| Lot Number | M931770 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTEC, INC. (CIVCO) |
| Manufacturer Address | 1401 8TH ST. S.E. ORANGE CITY IA 51041 US 51041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-05 |