MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-27 for STERITATT MARKING DEVICE ORDER CODE 700 manufactured by Se Moulding Inc..
[16012827]
Patient received medical tattoo for markings of site for radiation treatment, chest wall is site of tattoo. On (b)(6) 2013 patient complained of discomfort at site and has inflammation of skin and soft tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3193698 |
| MDR Report Key | 3193698 |
| Date Received | 2013-06-27 |
| Date of Report | 2013-06-14 |
| Date of Event | 2013-05-20 |
| Date Facility Aware | 2013-06-13 |
| Report Date | 2013-06-14 |
| Date Reported to FDA | 2013-06-17 |
| Date Reported to Mfgr | 2013-06-17 |
| Date Added to Maude | 2013-07-01 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERITATT MARKING DEVICE |
| Generic Name | MEDICAL TATTOO MARKING DEVICE |
| Product Code | JAC |
| Date Received | 2013-06-27 |
| Catalog Number | ORDER CODE 700 |
| Lot Number | 065 |
| Device Expiration Date | 2014-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SE MOULDING INC. |
| Manufacturer Address | 6 MILL STREET, MT HOLLY SPRINGS PA 17065 US 17065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-27 |