MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-10-14 for PROTOCOL TOUCH SN390305-5158 manufactured by Bracco Diagnostics Inc.
| Report Number | 2411512-2019-00006 |
| MDR Report Key | 9186333 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-10-14 |
| Date of Report | 2019-09-26 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2019-10-29 |
| Date Added to Maude | 2019-10-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PROTOCOL TOUCH |
| Generic Name | PROTOCOL TOUCH |
| Product Code | FCX |
| Date Received | 2019-10-14 |
| Model Number | SN390305-5158 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO DIAGNOSTICS INC |
| Manufacturer Address | 155 PINELAWN ROAD SUITE 230N MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-14 |