MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for CAPTUS 4000E 5430-301542 manufactured by Mirion Technologies (capintec), Inc..
| Report Number | 2518443-2019-00002 |
| MDR Report Key | 9166032 |
| Date Received | 2019-10-08 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2019-09-19 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2019-10-08 |
| 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 |
| Manufacturer Contact | MS. MARY YUSKO |
| Manufacturer Street | 7 VREELAND DRIVE |
| Manufacturer City | FLORHAM PARK NJ 07932 |
| Manufacturer Country | US |
| Manufacturer Postal | 07932 |
| Manufacturer Phone | 2018259500 |
| Manufacturer G1 | MIRION TECHNOLOGIES (CAPINTEC) INC. |
| Manufacturer Street | 7 VREELAND ROAD |
| Manufacturer City | FLORHAM PARK NJ 07932 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07932 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTUS 4000E |
| Generic Name | THYROID UPTAKE SYSTEM |
| Product Code | IZD |
| Date Received | 2019-10-08 |
| Model Number | 5430-301542 |
| Catalog Number | 5430-301542 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIRION TECHNOLOGIES (CAPINTEC), INC. |
| Manufacturer Address | 7 VREELAND ROAD FLORHAM PARK NJ 07932 US 07932 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-08 |