MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for ROCKET MEDICAL 5FGHSG SONOHYSTOGRAM CATH R57422 manufactured by Rocket Medical Plc.
[180889795]
Balloon on hsg catheter failed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093207 |
| MDR Report Key | 9744638 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-12 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ROCKET MEDICAL 5FGHSG SONOHYSTOGRAM CATH |
| Generic Name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-02-21 |
| Model Number | R57422 |
| Lot Number | 480661 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCKET MEDICAL PLC |
| Manufacturer Address | HINGHAM MA 02043 US 02043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |