MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-11 for HYDROMARK manufactured by Devicor Medical Products, Inc..
| Report Number | 8992347 |
| MDR Report Key | 8992347 |
| Date Received | 2019-09-11 |
| Date of Report | 2019-04-23 |
| Date of Event | 2018-08-15 |
| Report Date | 2019-04-23 |
| Date Reported to FDA | 2019-04-23 |
| Date Reported to Mfgr | 2019-09-11 |
| Date Added to Maude | 2019-09-11 |
| 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 | HYDROMARK |
| Generic Name | MARKER, RADIOGRAPHIC, IMPLANTABLE |
| Product Code | NEU |
| Date Received | 2019-09-11 |
| Lot Number | F11814464D |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVICOR MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 300 E-BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-11 |