MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-19 for TOMTEC-ARENA TTA2 manufactured by Tomtec Imaging Systems Gmbh.
| Report Number | 8043836-2019-00001 |
| MDR Report Key | 9086360 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-19 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-05-29 |
| Date Mfgr Received | 2019-05-29 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. HANS BEINKE |
| Manufacturer Street | EDISONSTRASSE 6 |
| Manufacturer City | UNTERSCHLEISSHEIM, 85764 |
| Manufacturer Country | GM |
| Manufacturer Postal | 85764 |
| Manufacturer G1 | TOMTEC IMAGING SYSTEMS GMBH |
| Manufacturer Street | EDISONSTRASSE 6 |
| Manufacturer City | UNTERSCHLEISSHEIM, 85764 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 85764 |
| 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 TTA2 |
| Generic Name | IMAGE REVIEW AND QUANTIFICATION SOFTWARE |
| Product Code | LLZ |
| Date Received | 2019-09-19 |
| Model Number | TTA2 |
| Lot Number | 20.14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |