MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-19 for TOMTEC-ARENA TT2 TTA2 manufactured by Tomtec Imaging Systems Gmbh.
| Report Number | 8043836-2019-00002 |
| MDR Report Key | 9087767 |
| Date Received | 2019-09-19 |
| Date of Report | 2019-11-12 |
| Date of Event | 2016-06-14 |
| Date Added to Maude | 2019-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 8043836-10/02/19-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOMTEC-ARENA TT2 |
| Generic Name | IMAGE REVIEW AND QUANTIFICATION SOFTWARE |
| Product Code | LLZ |
| Date Received | 2019-09-19 |
| Model Number | TTA2 |
| Lot Number | 11.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOMTEC IMAGING SYSTEMS GMBH |
| Manufacturer Address | EDISONSTRASSE 6 UNTERSCHLEISSHEIM, 85764 GM 85764 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-19 |